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Biotech / Medical : Introgen Therapeutics -- Ignore unavailable to you. Want to Upgrade?

To: zeta1961 who wrote (253)	3/23/2005 5:31:24 PM
From: tuck	Read Replies (1) \| Respond to of 802

I agree the bear case for failure is pretty twisted. The real bear case would be that we don't know what's happening in PIII because it isn't anywhere near done. You and others have emphasized the critical issue of the number of patients available for trials (for example, Derek Lowe's blog addressed just that issue last night corante.com ). Though INGN won't get specific on enrollment numbers for the trial, I think it is safe to say that it is enrolling more slowly than had been projected/hoped, and that is why they are going for a rolling BLA/PII-based approval. If this dynamic persists and creates share price weakness this summer, I may reload the shares I sold (will get interested -- ceteris parabis -- ~$6.50). Under this scenario, the immediate risk is not clinical but regulatory. So from the timing-of-investment perspective, the key issue is not the PIII but the timeline regarding the FDA's decision to accept INGN's proposal . . . >>the FDA has requested we submit existing new data and analyses from the Phase 2 ADVEXIN therapy clinical trials for recurrent head and neck cancer.<< Has INGN indicated where they are with respect to submission of this data, and what the expected time to response from the FDA would be? If not, have you or anyone made a plausible educated guess? TIA & Cheers, Tuck