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Woland
credo che pochissimi la ricorderanno, era una ciofeka che andava di moda su WSI ...

http://forum.wallstreetitalia.com/forum/to...Title=WSI+FORUM

da 4 sedute sono ritornati i volumi
come azienda non è messa bene ...

InSite Vision Completes $9 Million Private Financing
5/26/2005 4:46:01 PM



InSite Vision Incorporated (ISV) - an ophthalmic therapeutics, diagnostics and drug-delivery company - today announced it has completed its previously announced $9 million private financing of common stock and warrants for common stock. New York-based Paramount BioCapital, Inc. served as the placement agent for this financing.


"With this financing completed, we are now able to more fully concentrate on completing our Phase 3 pivotal trials with AzaSite™, as well as our other programs," said S. Kumar Chandrasekaran, Ph.D., InSite Vision's president and chief executive officer.

The terms of the agreements provided for the sale of approximately 16.4 million newly issued shares of common stock at $0.55 per share, and the issuance of warrants to purchase approximately 4.9 million shares of common stock at an exercise price of $0.6325 per share. The warrants have a term of five years and will not be exercisable or transferable for six months.

InSite Vision is obligated to file with the U.S. Securities and Exchange Commission a resale registration statement relating to the common stock to be issued in the transaction and the shares of common stock to be issued upon the exercise of the warrants as well as the shares of common stock underlying warrants to be issued to the placement agent.

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InSite Vision Announces Issuance of an EPO Patent on Azalide Antibiotics for Use in the Eye
6/8/2005 7:00:07 AM

ALAMEDA, Calif., Jun 08, 2005 (BUSINESS WIRE) -- InSite Vision Incorporated (ISV) -- an ophthalmic therapeutics, diagnostics and drug-delivery company -- today announced that the European Patent Office has issued a patent assigned to InSite Vision titled "Azalide Antibiotics For The Topical Treatment Or Prevention Of Ocular Infections". The issued EPO patent covers azalide antibiotic formulations utilizing DuraSite to topically treat ocular infections alone or in combination with other pharmaceutical compounds.


InSite Vision incorporates azithromycin, an azalide, in the AzaSite™ anti-infective formulation and is developing the product for the topical treatment of bacterial conjunctivitis. InSite is also developing AzaSite Plus™ which is a combination of azithromycin with a steroid to treat inflammation and infection related conditions of the eye.

InSite Vision is presently conducting two pivotal Phase 3 trials with AzaSite for the treatment of bacterial conjunctivitis. Pending successful completion of these Phase 3 clinical trials with satisfactory results, subsequent filing of a new drug application (NDA) and approval from the U.S. Food and Drug Administration (FDA), the Company expects to commercially launch AzaSite in the U.S. in the second half of 2006.

"We are extremely pleased with this patent issuance as it will allow InSite Vision to protect its proprietary rights which will be important for potential commercialization of both AzaSite and AzaSite Plus in Europe," stated S. Kumar Chandrasekaran, Ph.D., InSite Vision's president and chief executive officer.

About InSite Vision

InSite Vision is an ophthalmic company focused on ocular infections, glaucoma and retinal diseases. The Company's lead product is AzaSite, which targets infections of the eye. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic formulated with DuraSite®, InSite Vision's patented drug-delivery vehicle, which offers the benefit of a less frequent, low-dosing regimen, attractive to both the eye-care patient and physician. The Company intends to seek to expand this "technology platform" to include additional indications and product options for the worldwide market.

In the glaucoma area, the Company has continued to focus genomic research on the TIGR gene, among other genes in its genomic portfolio. A portion of this research has been incorporated into the Company's commercially available OcuGene® glaucoma genetic test for disease management, which is a prognostic tool designed to detect a genetic marker (mt-1) in the promoter region of the glaucoma-related TIGR gene. Additional information can be found at www.insitevision.com.

This press release contains, among other things, certain statements of a forward-looking nature relating to future events or the future business performance of InSite Vision. Such statements entail a number of risks and uncertainties, including but not limited to: InSite Vision's ability to enroll patients in and to complete future clinical trials for AzaSite; the results of these clinical trials; InSite Vision's ability to commence, complete and file a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for AzaSite, and receive approval from the FDA for the commercialization of AzaSite; the timing of the commercialization of AzaSite; InSite Vision's ability to obtain additional financing; InSite Vision's ability to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others; InSite Vision's ability to negotiate, enter into and maintain collaborations and commercial agreements with potential corporate partners; its ability to obtain market acceptance of its products and product candidates; its reliance on third parties for the development, marketing and sale of its products; its ability to expand its technology platform to include additional indications and patent options; and the effects of its expense control activities on its operations and product development. For a discussion of these and other factors that could cause actual events or results to differ from those anticipated by our forward-looking statements, see the discussion of risk factors detailed in InSite Vision's filings with the Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly reports on Form 10-Q. These risk factors may not be exhaustive. Any projections in this press release are based on the limited information currently available to InSite Vision, which is subject to change. New risk factors may emerge from time to time, and InSite Vision cannot predict such new risk factors, nor can it assess the impact, if any, of such new risk factors on our business or events described in any forward-looking statements. Although any such projections and the factors influencing them will likely change, InSite Vision undertakes no obligation to update the information. Such information speaks only as of the date of its release. Actual events or results could differ materially and one should not assume that the information provided in this release is still valid at any later date.

Note to Editors: OcuGene is written with a "small cap" G; if doing so is not possible, please use an upper case G. InSite Vision Incorporated, InSite Vision, DuraSite and OcuGene are trademarks of InSite Vision Incorporated. Other trademarks that may be mentioned in this release are the intellectual property of their respective owners.

SOURCE: InSite Vision Incorporated

InSite Vision Incorporated
S. Kumar Chandrasekaran, 510-865-8800
Sandra Heine, 510-865-8800
www.insitevision.com


Copyright Business Wire 2005
Woland
2 years


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InSite Vision Meets with the FDA on Pre-NDA Discussions for AzaSite
6/22/2005 1:06:02 PM



ALAMEDA, Calif., Jun 22, 2005 (BUSINESS WIRE) -- InSite Vision Incorporated (ISV) -- an ophthalmic therapeutics, diagnostics and drug-delivery company -- today announced a pre-NDA meeting with representatives of the U.S. Food and Drug Administration (FDA) was held on Tuesday, June 21, 2005. The purpose of the meeting was to discuss sections of the proposed new drug application (NDA) submission for AzaSite™, the company's ocular anti-infective. AzaSite is currently in late-stage development for the treatment of bacterial conjunctivitis.


"This meeting, which is a part of the normal regulatory review process, demonstrates additional progress in our efforts to gain regulatory approval for AzaSite," said S. Kumar Chandrasekaran, Ph.D., InSite Vision's chief executive officer. "Our discussions with the FDA during this meeting will facilitate our full NDA submission. We are exceptionally pleased with this meeting as it further marks a step toward product introduction."

During the meeting with the FDA, InSite Vision reviewed formatting of the pre-clinical and chemistry, manufacturing and controls (CMC) sections, preclinical data inclusion, and data inclusion for product dating which comprises more than half of the submission. Pending successful completion of and satisfactory results from current ongoing Phase 3 clinical trials and the subsequent filing of the full NDA and approval from the FDA, the Company expects to commercially launch AzaSite in the U.S. in the second half of 2006.
Woland
siamo sulla rossa .72 max .75
Woland
bei volumi in salita x questo ciofekone 102.gif
Woland
p.p.p.q 102.gif
Woland
ALAMEDA, Calif., Sep 22, 2005 (BUSINESS WIRE) -- InSite Vision Incorporated (ISV, Trade) an ophthalmic therapeutics, diagnostics and drug-delivery company today announced that it has signed a manufacturing supply agreement with Cardinal Health for the manufacture of topical AzaSite™ (1% azithromycin) commercial units. Cardinal Health has manufactured the clinical trial supplies currently being used in InSite Vision's two Phase 3 bacterial conjunctivitis clinical trials, and also the registration batches to be used for the AzaSite New Drug Application (NDA) filing.

InSite Vision formulates azithromycin, an azalide antibiotic, in InSite Vison's DuraSite® ophthalmic drug delivery system. AzaSite will be used for the treatment of bacterial conjunctivitis. Additionally, InSite Vision is developing AzaSite Plus™,which is a combination of azithromycin with a steroid, to treat inflammation/infection related conditions of the eye.

Under the terms of this agreement, Cardinal Health will be responsible for the manufacture, packaging and release testing of commercial AzaSite units when the product receives FDA approval. InSite Vision is currently working with Cardinal Health on the manufacturing process and validation for commercial production of the AzaSite product.

"We continue to make excellent progress in assembling the pieces necessary to support the commercial launch of the product," said S. Kumar Chandrasekaran, Ph.D., chief executive officer of InSite Vision. "The establishment of this manufacturing agreement with Cardinal Health will form a cornerstone for the commercialization of the AzaSite franchise."
Woland
.8 max intraday .79 now supervolumi 102.gif
Woland
vediamo se tiene .82 in chiusura tanti_documenti.gif
ammiraglio
WOLAND, DACCI UN'OCCHIO E DIMMI CHE NE PENSI. LA SEGUO DA QUALCHE GIORNO. STASERA CI SONO GLI EARNINGS.

VIVO -MERIDIAN BIOSCIENC 21:41 $20,95 -0,06 -0,29% 267.949
Woland
veramente la trim l'hanno data ieri, e ad una rapida occhiata è buona

http://www.marketwatch.com/tools/quotes/ne...3B52E194CCE0%7D
Woland
InSite Vision Announces Positive Top-Line Results from First of Two Pivotal Phase 3 Clinical Trials; Pivotal Trial Succeeds in Reaching Primary Efficacy Endpoint of Clinical Resolution

11/30/2005 7:00:05 AM


ALAMEDA, Calif., Nov 30, 2005 (BUSINESS WIRE) -- InSite Vision Incorporated (ISV) today announced positive top-line results from a pivotal phase 3 clinical trial of AzaSite™, a sterile, topical ophthalmic anti-infective solution containing 1.0% azithromycin formulated in DuraSite® (the Company's patented drug delivery system). In an international, controlled clinical trial, subjects with bacterial conjunctivitis (pink-eye) were treated with either AzaSite dosed twice a day for the first 2 days, followed by once a day for the next 3 days or 0.3% tobramycin dosed four times a day for 5 days. AzaSite demonstrated a clinical resolution rate of 80% as compared to 78% for tobramycin. This result shows that the clinical resolution rate of AzaSite is equivalent to tobramycin, the primary efficacy endpoint of the study, according to statistical criteria which were previously agreed to by the FDA. The bacterial eradication rate was also equivalent for both groups.

S. Kumar Chandrasekaran, Ph.D., InSite Vision's CEO stated, "The results of this phase 3 clinical trial demonstrate that AzaSite is effective against bacterial conjunctivitis using a significantly reduced dosing frequency. The clinical resolution rate of less frequently dosed AzaSite is comparable to the best selling ophthalmic antibiotic products. The reduced dosing frequency can lead to improved compliance, greater patient convenience and better therapeutic outcomes. This result is a major milestone achievement in the preparation for the AzaSite NDA filing in 2006."

Phase 3 study design

The phase 3 clinical trial was a double-blind, randomized, active-controlled study that enrolled patients ranging in age from 1 to 93 years with bacterial conjunctivitis. Patients with presumed bacterial conjunctivitis were enrolled on day 1 and a conjunctival culture was taken to demonstrate bacterial infection. All culture results were analyzed by a large central laboratory. The active control in the study was tobramycin, USP 0.3% ophthalmic solution, a broad-spectrum topical antibiotic. The treatment regimen lasted 5 days. The aim of the study was to show equivalent efficacy between patients dosed for 5 days with AzaSite versus tobramycin, AzaSite being less frequently dosed. There were a total of 47 clinical enrolling sites involved in the study; 41 in the United States and 6 in Latin America. A total of 746 subjects were enrolled in the study of which 316 had positive bacterial cultures. Among the culture positive subjects, 59% were pediatric and 41% were adult.

Treating bacterial conjunctivitis with AzaSite

The top line statistical analysis was performed on unblinded study data. Preliminary safety data from the phase 3 study showed that AzaSite was well tolerated in adult and pediatric patients. There were no reports of systemic drug sensitivity due to study medication. No serious adverse events were reported by the clinical sites. Ocular adverse events were minimal in frequency and equivalent between the two groups. Further, there were no reports of blurred vision related to the study medications. Further statistical analysis of the data is continuing. The final results will be presented in an upcoming international ophthalmic conference.

Conference Call


S. Kumar Chandrasekaran, Ph.D., Chief Executive Officer will host a conference call beginning at 10:30 a.m. Eastern Time today to discuss these top-line clinical results and answer questions. Dr. Eugene E. Protzko, clinical instructor at the University of Maryland School of Medicine and a principal investigator in the clinical trial will present his perspective on the study and answer questions during the call.

Individuals interested in listening to the conference call may do so by dialing (800) 475-3716 for domestic callers or 719-457-2728 for international callers. A telephone replay will be available for 48 hours following the conclusion of the call by dialing 800-203-1112 for domestic callers or 719-457-0820 for international callers. Callers will have to enter the Replay Passcode: 2904045.

The live conference call will also be available via the Internet on the investor relations section of the Company's Web site at www.insitevision.com, and a recording of the call will be available for 90 days following the completion of the call.
Woland
.88 siamo sui max de giornata, bei volumi 102.gif
Woland
a .95 c'è un muro, ffaiper, famme un po 'de fresco laugh.gif
Max
ritardato laugh.gif
Woland
1.72 max un mese fa, poi un po' de sell



http://www.marketwatch.com/News/Story/Stor...sid=11357&symb=
Woland
livello critico, se non passa 1.55 si va 20 tick sotto
i vol so' sozzi
Woland
terminato febbraio mese de cazzeggio, si riparte alla grande , vediamo se già in serata se fanno nuovi max 102.gif



1 year weekly

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Woland
vabbè, mancano ancora due mesi ...


InSite Vision to Present Results From First of Two Phase 3 Clinical Trials at International Vision Meeting



ALAMEDA, Calif., Feb 22, 2006 (BUSINESS WIRE) -- InSite Vision Incorporated (ISV : InSite Vision Inc


3:47pm 03/01/2006


ISV1.69, +0.21, +14.2%) , an ophthalmic company focused on ocular infections, glaucoma and retinal diseases, announced today the acceptance of two abstracts related to the first of its two phase 3 trials of the topical eye drop anti-infective AzaSite (1% azithromycin in DuraSite®). The research results will be presented at the upcoming meeting of the Association for Research in Vision and Ophthalmology at the Fort Lauderdale Convention Center in Ft. Lauderdale, Florida, to be held April 30 - May 4, 2006. Safety and efficacy results from the phase 3, active-controlled, prospective, multi-center, bacterial conjunctivitis trial are scheduled for presentation as follows:

-- Wednesday, May 3: A Randomized Trial Assessing Microbial Eradication and Clinical Efficacy of 1% Azithromycin Ophthalmic Solution vs. Tobramycin in Adult Subjects With Bacterial Conjunctivitis. Mark Abelson, MD; Eugene Protzko, MD; Aaron Shapiro, Ph.D.; and the AzaSite Clinical Study Group.

-- Thursday, May 4: A Randomized Trial Assessing Safety and Tolerability of 1% Azithromycin Ophthalmic Solution vs. Tobramycin in Adult Subjects. Eugene Protzko, MD; Mark Abelson, MD; Aaron Shapiro, Ph.D.; and the AzaSite Clinical Study Group.

AzaSite contains 1% azithromycin, a broad-spectrum antibiotic. Top line efficacy results for the active-controlled study were first reported in November 2005. There were 47 clinical enrolling sites involved in the study: 41 in the United States and 6 in Latin America. A total of 746 subjects aged 1 year or older were enrolled in the study with 316 positive bacterial cultures. Subjects in the trial were evaluated for clinical resolution, microbial eradication, safety and tolerability. Among the culture positive subjects, 59% were pediatric and 41% were adult. In January 2006, the company announced the completion of enrollment for the second of its two phase 3 clinical studies with AzaSite for the treatment of bacterial conjunctivitis and unblinded efficacy results are anticipated next month.

About InSite Vision Incorporated

InSite Vision is an ophthalmic company focused on developing therapies that treat ocular infections, glaucoma and retinal diseases. The Company's lead product is AzaSite, which targets infections of the eye. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic formulated with DuraSite, InSite Vision's patented drug-delivery vehicle, which offers the benefit of a low-dosing regimen, attractive to both the eye-care patient and physician. Pending the successful results of phase 3 clinical testing currently underway and filing and approval of an NDA with the FDA, the Company currently expects AzaSite to be commercially launched in the United States, while seeking to expand this "technology platform" to include additional product candidates and indications for the worldwide market.
In the glaucoma area, the Company continues to focus genomic research on the TIGR gene, among other genes in its genomic portfolio. A portion of this research has been incorporated into the Company's commercially available OcuGene® glaucoma genetic test for disease management, which is a prognostic tool designed to detect a genetic marker (mt-1) in the promoter region of the glaucoma-related TIGR gene.
Woland
mi sa che oggi è meglio levare le tende sui max, vediamo


http://www.marketwatch.com/News/Story/Stor...sid=11357&symb=
Woland
2.08 de max
volumeria
Woland
rosio, ti ho dato un buy sul gap down e crollo in apertura alle 15.37 di giovedì 30 marzo in via confidenziale tramite e-mail: se non l'hai presa te frusto cor gatto a nove code 44.gif laugh.gif

here I am again 102.gif
Woland
si è liberata dell'incognita trim

nuovi max de periodo 102.gif
rosio
CITAZIONE(Woland @ Saturday, 1 Apr 2006, 03:25)
rosio, ti ho dato un buy sul gap down e crollo in apertura alle 15.37 di giovedì 30 marzo in via confidenziale tramite e-mail: se non l'hai presa te frusto cor gatto a nove code 44.gif laugh.gif

here I am again 102.gif

sei un amico ma io non ho la possibilità di seguire nemmeno il mio cervello questi giorni ... bentornato !!
Woland
sale con volumi nel canale, TP 2.85 superman.gif
Woland
ISV tiene bene in n mese d'inferno
Woland
2.7 de max intraday, tanti_documenti.gif 2.69 now
Woland
dopo le mazzate di nuovo interessante, su 1.6 potrebbe essere un ottimo buy
Woland
June 29, 2006 07:00:00 AM ETInSite Vision Announces Submission of AzaSite™


All Business Wire NewsInSite Vision Incorporated ISV -- an ophthalmic products company currently developing therapies that treat ocular infection, glaucoma, and retinal diseases, today announced it has submitted to the United States Food and Drug Administration (FDA) a New Drug Application (NDA) for AzaSite™ for the treatment of bacterial conjunctivitis. AzaSite combines a topical 1% azithromycin formulation with InSite's patented DuraSite® ophthalmic drug-delivery system that increases ocular retention of the drug.


Related newsMarket Report -- In Play (ISV)

InSite Vision has completed the compilation and assembly of a hybrid electronic NDA filing in a modified Common Technical Document (CTD) format. This submission incorporates the positive results from the recently completed Phase 3 clinical trials, pre-clinical studies, chemistry, manufacturing and controls. InSite previously announced the completion of these two Phase 3 studies including a vehicle controlled study versus AzaSite and a study comparing 0.3% tobramycin versus AzaSite. The results of these trials showed that AzaSite was safe, well tolerated and efficacious in the treatment of bacterial conjunctivitis.

Kumar Chandrasekaran, Ph.D., InSite Vision's Chief Executive Officer, stated, "The submission of the AzaSite NDA is a major milestone for InSite Vision and brings our lead product one very significant step further in the FDA approval process. We anticipate the launch of AzaSite in early 2007 as we pursue development of additional products that make up the AzaSite franchise."

Dr. Chandrasekaran added: "The fundamental characteristics of the AzaSite franchise remain strong and are enhanced by our significant progression announced today in our pursuit to reach commercialization for the product. Furthermore, our corporate partnership discussions are continuing as previously indicated. Our efforts in this matter are designed to ensure that we provide our product franchise with the most effective conduit to the various medical specialties, to maximize patient and physician acceptance, market opportunity and, importantly, shareholder value. Details of the finalized corporate relationships will be provided when available."
Woland
CITAZIONE(Woland @ Friday, 23 Jun 2006, 15:40) *
dopo le mazzate di nuovo interessante, su 1.6 potrebbe essere un ottimo buy


1.74 in close sui max de giornata, 2 tick sopra c'è un un muretto, poi si andrebbe oltre i 2 $

anche qui un grafico non ci starebbe male, thanks tanti_documenti.gif
DragonFly
txsII
Woland
InSite Vision Announces $6.3 Million Private Placement

Last Update: 7:01 AM ET Aug 3, 2006


ALAMEDA, Calif., Aug 03, 2006 (BUSINESS WIRE) -- InSite Vision Incorporated (ISV : InSite Vision Inc

Last: 1.49+0.17+12.89%

9:49am 08/03/2006

:
ISV1.49, +0.17, +12.9%) today announced it has entered into definitive agreements for a $6.3 million private placement of common stock and warrants for common stock. Closing of the financing is contingent on approval from the American Stock Exchange, among other standard conditions. The terms of the agreements provide for the sale of approximately 4.8 million newly issued shares of common stock at the five day trailing weighted average price of $1.31 per share, and the issuance of warrants to purchase approximately 1.0 million shares of common stock at an exercise price of $1.51 per share. The warrants have a term of five years, must be exercised in cash and may only be exercised after six months following the closing of the private placement.
The private placement is to be made to three of InSite Vision's current institutional investors, Balyasny Asset Management, PTV Sciences and a large Boston-based institutional investment management firm. InSite Vision is obligated to file with the U.S. Securities and Exchange Commission a resale registration statement relating to the common stock to be issued in the transaction and the shares of common stock to be issued upon the exercise of the warrants. RBC Capital Markets Corporation acted as placement agent for this transaction.
This press release does not constitute an offer to sell or the solicitation of an offer to buy the common stock or warrants of InSite Vision. The common stock and warrants to be issued in the private placement have not been registered under the Securities Act of 1933, as amended (the "Act") and may not be offered or sold in the United States absent registration under the Act or an applicable exemption from the registration requirements under the Act.
The proceeds from this financing, assuming its successful completion, will be used for its general corporate purposes including continued support of InSite Vision's AzaSite™ for the treatment of bacterial conjunctivitis, for which InSite submitted a new drug application (NDA) to the Food and Drug Administration (FDA) in June 2006. Additionally, this funding will enable InSite Vision to move forward with the anticipated filing of an investigational new drug application (IND) with the FDA this year for AzaSite Plus™, a combination product including AzaSite with an anti-inflammatory steroid.
S. Kumar Chandrasekaran, Ph.D., InSite Vision's chief executive officer stated, "The proposed financing discussed in today's announcement will provide InSite Vision with adequate liquidity to pursue near-term opportunities that are expected to grow the value of our company. In particular, this financing allows us time to continue pursuing the most compelling corporate partnership for the AzaSite franchise. As I have said all along, we are committed to consummating a partnership or other commercial option that provides our product franchise with the most effective conduit to the various medical specialties, to maximize patient and physician acceptance, market opportunity and, importantly, shareholder value."

Additional information can be found at the Company's website, www.insitevision.com.
Woland
InSite Vision to Present Results From Second of Two Pivotal Phase 3 Clinical Trials

Last Update: 9:01 AM ET Aug 3, 2006


ALAMEDA, Calif., Aug 03, 2006 (BUSINESS WIRE) -- InSite Vision Incorporated (ISV : InSite Vision Inc

Last: 1.45+0.13+9.85%

9:51am 08/03/2006

:
ISV1.45, +0.13, +9.8%) , an ophthalmic company focused on ocular infections, glaucoma and retinal diseases, announced today the acceptance of two abstracts related to its second pivotal trial of the topical eye drop antibiotic, AzaSite (1% azithromycin in DuraSite®). The vehicle-controlled, prospective, multi-center, bacterial conjunctivitis trial showed AzaSite was superior to the vehicle in both clinical resolution of the signs and symptoms of bacterial conjunctivitis as well as bacterial eradication. The efficacy and safety data will be presented at the upcoming meeting of the American Academy of Ophthalmology in Las Vegas, Nevada to be held November 11 - 14, 2006. The presentation schedule is as follows:
-- Efficacy of Azithromycin 1% Eye Drops vs. Vehicle as First-Line Therapy for Bacterial Conjunctivitis, Mark Abelson, MD, Warren Heller, MD, and the AzaSite Clinical Study Group.
-- Safety and Tolerability of 1% Azithromycin Eye Drops as Anti-infective Therapy for Bacterial Conjunctivitis, Warren Heller, MD, Mark Abelson, MD, and the AzaSite Clinical Study Group.
AzaSite contains 1% azithromycin, a broad-spectrum antibiotic. InSite Vision Inc. has completed two phase 3 studies. The results of these studies were submitted to the FDA on June 28, 2006 as part of the NDA to gain regulatory approval of AzaSite.
The first phase 3 study was a double-blinded, prospective, active-controlled bacterial conjunctivitis trial. It showed AzaSite dosed twice daily for the first 2 days and once daily for 3 more days was equivalent to tobramycin dosed four times daily for 5 days in resolving clinical signs and symptoms of bacterial conjunctivitis and eradicating offending bacteria. The second phase 3 study was a double-blinded, prospective, vehicle-controlled trial. It showed AzaSite was superior to the vehicle in both clinical resolution of the signs and symptoms of bacterial conjunctivitis and bacterial eradication. Both trials revealed a superior safety profile of AzaSite.
Kumar Chandrasekaran, Ph.D., InSite Vision's Chief Executive Officer, stated, "These clinical trial results support AzaSite's value proposition of established efficacy and coverage with the convenience and compliance of a once-a-day dosing regimen."
Woland
1.76 fine corsa , vediamo un po'
1.67 now
Woland
InSite Vision Announces 2nd Quarter, 2006 Earnings Conference Call to Be Held on August 14, 2006

Last Update: 7:00 AM ET Aug 7, 2006


ALAMEDA, Calif., Aug 07, 2006 (BUSINESS WIRE) -- InSite Vision Incorporated (ISV : InSite Vision Inc

Last: 1.75+0.06+3.55%

11:17am 08/07/2006

ISV1.75, +0.06, +3.6%) , an ophthalmic therapeutics, diagnostics and drug delivery company, announced today that the company will release 2006 second quarter financial results on Monday, August 14, 2006.
Kumar Chandrasekaran, PhD, Chief Executive Officer, and Sandra Heine, Vice President, Finance and Administration, will host a financial community conference call beginning at 9:00 a.m. EST on Monday, August 14, 2006 to discuss these results. Individuals interested in listening to the conference call may do so by dialing (877) 407-0778 for domestic callers and (201) 689-8565 for international callers. A telephone replay will be available for 48 hours following the conclusion of the call by dialing (877) 660-6853 for domestic callers and (201) 612-7415 for international callers. All callers will have to enter the conference ID 210914.
The live conference call will also be webcast and available on the Internet at www.InvestorCalendar.com as well as the Company's website at www.insitevision.com. A recording of the call will be available for 90 days following the completion of the conference.
Woland
siamo a 1.6 min di giornata
vedrei bene almeno 1.5
Woland
il II trim 06


http://www.marketwatch.com/News/Story/Stor...11357&symb=
Woland
di nuovo sopra ema 200

III Q 06

http://www.marketwatch.com/News/Story/Stor...11357&symb=
Woland
ciak, si gira
Woland
...
mora
cool.gif
il rally di dicembre dove la sta portando......
non vedo bn il prossimo semestre...
un saluto.... sad.gif
Woland
up
occhio allo scalone 1.77 tanti_documenti.gif
Woland
in watch absolutely
Woland
...
Woland
vol + 200 % in AH ha fatto 1.9

6 m d

Clicca per vedere l'allegato



3 y w

Clicca per vedere l'allegato
Woland
InSite Vision Announces FDA Approval for AzaSite™ Approval Triggers $19 Million Milestone Payment

8:37am 04/30/2007

<IMG class=pixelTracking height=1 width=1 border=0>ISV1.77, +0.20, +12.7%) - an ophthalmic therapeutics, diagnostics and drug delivery company, today announced that the U.S. Food & Drug Administration (FDA) has approved InSite's New Drug Application (NDA) for AzaSite (azithromycin 1% ophthalmic solution) for the treatment of bacterial conjunctivitis. AzaSite is formulated with DuraSite, InSite Vision's patented drug delivery vehicle which enhances the retention time of the antibiotic on the surface of the eye. AzaSite was shown to be safe and effective in two phase 3 clinical trials conducted in more than 1400 patients in the U.S. and Latin America. In these clinical studies which were designed and conducted in concert with Mark Abelson, M.D. and Ophthalmic Research Associates, AzaSite was administered twice daily on the first two days, then once daily on days 3-5. The results demonstrated that AzaSite provided clinically and statistically significant improvements in clinical resolution of symptoms and bacterial eradication compared to placebo; and was equivalent in clinical resolution and bacterial eradication when compared to tobramycin administered four times a day for 5 days. The principal investigators, Doctors Warren Heller and Eugene Protzko, respectively, formally presented these study results at the 2006 American Academy of Ophthalmology Annual Meeting and at the Association for Research in Vision and Ophthalmology Annual Meeting. "We are truly delighted with the AzaSite product approval," said S. Kumar Chandrasekaran, Ph.D., InSite Vision's Chief Executive Officer. "This approval and our related commercialization agreement with Inspire Pharmaceuticals for the U.S. and Canada represent major accomplishments for our company and will now automatically trigger the milestone payment of $19 million. Our objective is to provide both the patient and the physician with a convenient and highly effective alternative for the treatment of bacterial conjunctivitis. We expect Inspire Pharmaceuticals to utilize an expanded sales force to launch AzaSite later this year." Christy L. Shaffer, Ph.D., President and CEO of Inspire, commented, "We congratulate InSite Vision on the achievement of this important milestone in the development of AzaSite. We are dedicating significant resources to making AzaSite available to patients as soon as possible." Terrence P. O'Brien, M.D., Professor of Ophthalmology and Charlotte Breyer Rodgers Distinguished Chair in Ophthalmology, at the Bascom Palmer Eye Institute of the University of Miami, commented, "AzaSite is a significant new ophthalmic product for the treatment of bacterial conjunctivitis. This unique formulation of the well-known, broad-spectrum antibiotic, azithromycin, results in a more convenient topical dosing regimen, requiring less than half the number of drops for effective treatment compared to currently available products. These attributes are particularly important when treating young children and busy adults."


guardare anche ISPH
Woland
ciofekone era e tale è rimasto. tentativi de ristrutturà,, il delisting è dietro l'angolo
ieri botto volumato sulle news, venderanno il solito AzaSite anche in Canada
guardare , ma non comprare
Woland
InSite Vision IncISV (NYSE-Alt) 0.30Change:+0.04+15.00%Volume:384,056 [size="1"][/size]10:19am 4/2/2009

.3 ci stava, bel Chaikin, vediamo nei prox gg come consolida
Woland
CITAZIONE(Woland @ Thursday, 2 Apr 2009, 12:29) *
... il delisting è dietro l'angolo


ha svoltato !!! laugh.gif 111a.gif



http://biz.yahoo.com/e/090414/isv8-k.html
Woland
InSite Vision IncISV (NYSE-Alt) 0.29Change:-0.09-23.74%Volume:142,692 9:51am 4/15/2009
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