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Re: io_io post# 1667

Wednesday, 11/15/2006 4:51:02 PM

Wednesday, November 15, 2006 4:51:02 PM

Post# of 12660
BSR David's post on BTV

http://www.investorshub.com/boards/read_msg.asp?message_id=14823776

Read link and follow the thread back to PGS and Dew's comments. IMHO BSR David had cut though lots of the usual and often repeated FUD.

It comes down to if FDA will approve based on:

(1) The straight-up meaningful survival benefit in 9901 and in pre-specified pooled 9901 & 9902a analysis

(2) View as supportive the other analysis -- each of the three pre-specified Cox (9901, 9902a & pooled), CD-54 upreg as predictor of survival, exploratory analysis showing synergy with chemo (14+ mos or 71% increase in median survival versus chemo alone), and preliminary evidence of efficacy in ADPC via P11.

(3) very high therapeutic index (minimal side-effects vs compelling benefit)

(4) FDA has the option of approving on accelerated basis or on full basis, where they can force the drug off the market if 9902b (aka Impact) reveals any disturbing data within 12 mos of approval.

So balance all of the above against the negatives -- primary analysis was TTP, which failed, and that 9902a stand-alone did not show survival benefit.

At market cap of below $400 mm with enough cash to get beyond FDA decision the stock is IMHO very attractive.

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