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ISV - Sector: Healthcare --- Industry: Biotechnology & Drugs

Started by setravis, June 13, 2005, 06:20:55 PM

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la-onda

interesting chart & news IMO  >:D

Insite Drug Under Review by the FDA
Monday August 28, 12:28 pm ET
Insite Vision Awaiting FDA Decision on Conjunctivitis Treatment Candidate.

ALAMEDA, Calif. (AP) -- Insite Vision Inc., maker of treatments for eye diseases, said Monday it asked the Food and Drug Administration to approve its bacterial conjunctivitis treatment, Azasite.

The new drug application, now under review by the FDA, includes results from three clinical trials involving 698 patients. The studies showed Azasite, the company's lead product candidate, were effective in reducing symptoms and getting rid of bacteria. The company hopes to launch the product early next year.

Bacterial conjunctivitis is a common condition in which the mucous membrane of the eye becomes infected.

Shares of Insite rose 9 cents, or 5.6 percent, to $1.70 on the American Stock Exchange in midday trading. The stock has traded between 48 cents and $2.70 over the last 52 weeks.

fous

This one of my picks for tomorrow O, you hoppin in?

ISV approved for NDA filing review:
QuoteALAMEDA, Calif.--(Business Wire)--Aug. 28, 2006-- InSite Vision Incorporated (AMEX:ISV) -- an ophthalmic therapeutics, diagnostics and drug delivery company, today announced the U.S. Food and Drug Administration has accepted for filing and comprehensive review, InSite Vision's NDA for AzaSite (azithromycin 1% ophthalmic solution), indicated 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 target tissue.

The NDA contains data from two phase 3 clinical trials in which 698 patients were treated with AzaSite. Data from these studies demonstrated that when AzaSite was administered twice daily on the first two days, then once daily on days 3-5, it 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.

S. Kumar Chandrasekaran, Ph.D., InSite Vision's chief executive officer stated, "Today's announcement of the FDA acceptance and review of InSite Vision's NDA is a significant milestone which brings us one step closer to achieving our ultimate goal of the commercialization of our lead AzaSite product in early 2007. We expect a timely review by the FDA and look forward to hearing from them regarding next steps."

-fous
trade it like you mean it!

Melf Elf

Oliver and fous,

Volume was lacking, but that was a Double Ascending Triangle breakout yesterday.  There's a little Ascending Triangle (August 7 - to yesterday's breakout) nested within the larger pattern.  Nice find.   I get about the same target as fous.  Applaud you guys.

setravis

;)
Technicals and Growth Potential !
Microcap, strong technicals, potential near term 13/50 day crossover,
recent FDA submission.
Looks to be a cup and handle formation in the making......

Recent CandleStick Analysis
Bullish
Aug-28-2006 Bullish Harami 

Support @ $1.78...1.69...1.52...1.45
Resistance @ $1.87...2.01...2.08...2.15

MACD is Bullish
Stochastic is

52wk Range: 0.48 - 2.70

Technicals
Close Above the 50-day EMA

Last Price Quote is:
10.49%above 13-day EMA
10.12%above 50-day EMA
RS Rating: 5 

Fundamentals
Key Data:
Market Cap (M): $30.56 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: N/A
Last Analyst Rating: Buy
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

Se7en

Does this break of support at 1.80 does some technical damage  even if it closes at1.80 or above?
Així és la Catalunya, així és el Barça! Mès que un club!!!

Melf Elf

Quote from: Se7en on August 31, 2006, 01:09:05 PM
Does this break of support at 1.80 does some technical damage

Se7en,

We never want to see a stock go back below a breakout because, obviously, we have to consider the possibility that we had a false breakout.  (We need a cursing face on the toolbar when that happens).

For example, if it's a false breakout, the Ascending Triangle might have "morphed" (changed) into a Bear Flag (the parallel lines drawn in red).

It isn't technically damaged at this point, but it would be if we take out the ascending line (blue) and the bottom of the "possible" Bear Flag (red)

Quote
even if it closes at1.80 or above?

As long as a stock closes at or above a breakout (1.80 in this case) I consider the target(s) still to be IN PLAY.

A close back below 1.80, the target goes ON HOLD until we see what's going on.  That's a "gut check" time when a target goes ON HOLD.  Do we still want to hold it?  What do we like about the stock, etc.  I sometimes "abandon ship" when a stock goes ON HOLD.

If the support that I mentioned (at about 1.65) gets broken, the upside target is CANCELLED, and we then would have a downside target IN PLAY, based on the measurement of the possible Bear Flag.

Quote from: Melf Elf on August 30, 2006, 05:40:00 AM
Oliver and fous,

Volume was lacking, but that was a Double Ascending Triangle breakout yesterday.

The lack of volume on the breakout is something that I would consider in the decision-making process.

I also would consider the fact that the 50DMA just had a Bearish Cross below the 200DMA a week ago, etc.

Good luck if you have it.








Se7en

Així és la Catalunya, així és el Barça! Mès que un club!!!

setravis

ALAMEDA, Calif., Oct 02, 2006 (BUSINESS WIRE) -- InSite Vision Incorporated (ISV, Trade) -- an ophthalmic therapeutics, diagnostics and drug delivery company, is pleased to announce that Kumar Chandrasekaran, Ph.D., Chief Executive Officer will host the Company's 2006 Annual Shareholder meeting beginning at 1:00 pm EDT, Tuesday, October 3, 2006.

Immediately after the conclusion of the meeting, InSite Vision's management team will discuss key corporate initiatives including updates on the New Drug Application with the FDA for its lead topical anti-infective product AzaSite(TM) (ISV-401), new efforts surrounding its next major program, AzaSite Plus (ISV-502) and other corporate activities.

During the meeting the Company's stockholders will be asked to vote on three proxy items as outlined below:

-- The re-election of five directors to the Board of Directors of the Company;

-- An approval of an amendment to the Company's Restated Certificate of Incorporation (the "Certificate" or the "Restated Certificate of Incorporation") increasing the number of authorized shares of common stock from 120,000,000 to 240,000,000 shares; and

-- The ratification of the appointment of Burr, Pilger & Mayer LLP as independent public accountants of the Company for the fiscal year ending December 31, 2006.

The corporate presentation will be available live via webcast. To access the webcast, please go to the investor relations section of the Company's website at www.insitevision.com. A taped recording of the presentation will also be available after Tuesday October 3, 2006 for approximately one month.

About InSite Vision Incorporated

InSite Vision is an ophthalmic company focused on developing therapies that treat ocular infections, glaucoma and retinal diseases. InSite Vision'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 approval of its NDA with the FDA, InSite Vision 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, InSite Vision 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 InSite Vision's commercially available OcuGene(R) 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 our website, www.insitevision.com.

This news release and the webcast provided for hereunder contains, among other things, certain statements of a forward-looking nature relating to future events or the future business performance of InSite Vision, such as the Company's ability to obtain FDA approval of its NDA, discussion of he Companyh's efforts to engage a corporate partner for its AzaSite product, the anticipated date of commercialization of AzaSite and other product candidates, and the Company's product development plans. Such statements entail a number of risks and uncertainties, including but not limited to: InSite Vision's ability to obtain substantial additional funding to continue its operations; the results of InSite Vision's clinical trials; the ability to obtain FDA approval of its AzaSite NDA from the FDA for the commercialization of AzaSite and its other product candidates; the ability of InSite Vision to enter into a corporate collaboration for its AzaSite and other product candidates; the ability to launch AzaSite and the timing of such a launch; InSite Vision's ability to expand its technology platform to include additional indications and patent options; the effects of its expense control activities on its operations and product development; its ability to obtain regulatory approval and market acceptance of its products and product candidates, including its OcuGene glaucoma genetic test, AzaSite, ISV-205 and ISV-014; InSite Vision's ability to maintain and develop additional collaborations and commercial agreements with corporate partners, including those with respect to AzaSite and ISV-205; its reliance on third parties for the development, marketing and sale of its products; the initiation and results of preclinical and clinical studies; its ability to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others; determinations by the FDA, including those with respect to OcuGene, AzaSite and ISV-205 . Reference is made to 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, under the caption "Risk Factors." Any forward looking statements or projections are based on the limited information currently available to InSite Vision, which is subject to change. Although any such forward looking statements or 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(R) 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(R) and OcuGene(R) 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


Ashton Partners 
Barry Hutton, 888-857-7839 
www.ashtonpartners.com 

Copyright Business Wire 2006 ********************************************************************** As of Thursday, 09-28-2006 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated an UPTREND on 08-07-2006 for ISV @ $1.73. For more information on Comtex SmarTrend? Alert, contact your market data provider or go to CSTADirect.com SmarTrend is a registered trademark of Comtex News Network, Inc. Copyright ? 2004-2006 Comtex News Network, Inc. All rights reserved.




"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

Maintaining support.....

52wk Range: 0.59 - 2.70

Volume: 135,500
Avg Vol (3m): 236,533

Technicals
Last Price Quote is:
4.68%above 13-day EMA
1.06%above 50-day EMA
RS Rating: 71 

Fundamentals
Key Data:
Market Cap (M): $30.56 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: N/A
Last Analyst Rating: Buy

"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

la-onda

setravis, you are invested or are you waiting for the BO?

setravis

Quote from: la-onda on October 03, 2006, 12:10:22 PM
setravis, you are invested or are you waiting for the BO?


Invested........  8)
Have been holding this one many moons past ;D
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

Melf Elf

Quote from: Melf Elf on August 31, 2006, 02:57:00 PM
For example, if it's a false breakout, the Ascending Triangle might have "morphed" (changed) into a Bear Flag (the parallel lines drawn in red).

The Bullish Double Ascending Triangle breakout did, in fact, "morph" (change) into a Bear Flag.  :P

Quote
It isn't technically damaged at this point, but it would be if we take out the ascending line (blue)

The Ascending trendline broke to the downside on September 6.  :P

Quote
and the bottom of the "possible" Bear Flag (red)

The bottom of the Bear Flag broke on a gap down opening the next day, Septermber 7.  :P

Quote
If the support that I mentioned (at about 1.65) gets broken, the upside target is CANCELLED,

The upside targets were CANCELLED on the break of the Bear Flag.

Quote
and we then would have a downside target IN PLAY, based on the measurement of the possible Bear Flag.

The break of the Bear Flag put targets of 1.46 (the bottom of the Bear Flag) IN PLAY, and 1.21 IN PLAY.  The 1.46 target MADE.  The 1.21 target hasn't.  The September 27 low is 1.41

Math for the 1.21 target:

High of the Bear Flag: 1.97

Low of the Bear Flag: 1.46

1.97 - 1.46 = 0.51 points

The Bear Flag broke at 1.72 - 0.51 points = 1.21 IN PLAY

Targets don't always get MADE, like the Ascending Triangle targets that got CANCELLED when the Bear Flag formed, then broke to the downside, so we might not see the 1.21 target.  Just be aware, especially with 50/200 DMAs inverted, that it's still IN PLAY.



Melf Elf

Quote from: Melf Elf on August 31, 2006, 02:57:00 PM
If the support that I mentioned (at about 1.65) gets broken, the upside target is CANCELLED, and we then would have a downside target IN PLAY, based on the measurement of the possible Bear Flag.

At today's low of 1.24, ISV is within pennies of a downside target IN PLAY.

From the false breakout  (Bull Trap) at 1.81, ISV is down 31.49%

From the Bear Flag break at 1.68, ISV is down 26.2%.

UGH.

"Don't let a small loss (The break of the Bear Flag) turn into a disaster."



bocasva

I opened a position at 1.25 this morning, good bounce so far....

bocasva

This one really caught me by surprise today. I wasn't expecting such a quick move in one session....but they are welcome anytime.... >:D
I sold 1/2 of my position at 1.49 just before the close, after all that was a quick 20% profit.
Volume was kind of good but it ran so fast with no news (that I know of), plus it couldn't really break the 1.50 resistance and we also have 50 and 200 ema just above;so it was kind of risky not to take any profits off the table...
GLTA