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Replies to #75497 on Biotech Values
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mcbio

04/05/09 1:12 PM

#75517 RE: DewDiligence #75497

Re: VRUS - R7128 existing clinical safety data

Most toxicity issues show up in phase-2 when a new drug is combined with other treatments and is tested for 4 weeks or longer.



Thanks Dew, very helpful. It appears that based on the existing Phase 1 results, R7128 safety data has been comparable to placebo up to 4 weeks in combination with SoC. You summarized those results here: http://investorshub.advfn.com/boards/replies.aspx?msg=31999860

We'll see how the drug fares beyond 4 weeks in the upcoming Phase 2b. But, so far so good.
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iwfal

04/05/09 4:26 PM

#75520 RE: DewDiligence #75497

Investors have not yet subscribed to the idea of multiple direct antivirals in the same cocktail—either with the current SoC or without it.



Just out of curiousity, on what do you base this opinion?

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tony111

04/05/09 10:18 PM

#75532 RE: DewDiligence #75497

I would think most investors have subscribed to the idea of multiple direct antivirals cocktail. Just take a look at the stock price of companies developing better interferons.
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Biowatch

04/06/09 8:03 PM

#75562 RE: DewDiligence #75497

GILD says TEVA files ANDA for generic Atripla

http://finance.yahoo.com/news/Gilead-Sciences-Announces-bw-14863194.html

>>...Teva alleges that two of the patents associated with emtricitabine – U.S. Patent Numbers 6,642,245 and 6,703,396 – owned by Emory University and licensed exclusively to Gilead Sciences... will not be infringed by Teva...

Gilead... has 45 days from the date of receipt to commence a patent infringement lawsuit against Teva. Such a lawsuit would restrict the FDA from approving Teva’s ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first...

...In November 2008, Teva challenged the validity of these same two emtricitabine patents... with an ANDA filing for Truvada®... [GILD filed a lawsuit which] is ongoing.<<