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Biotech / Medical : Introgen Therapeutics

INGN 7.000

-0.4%

Nov 7 9:30 AM EST

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To: Jibacoa who wrote (229)	3/16/2005 10:01:12 PM
From: zeta1961	Read Replies (1) of 802

INGN CC..well..it's always a great conversation piece on the YMB<g>!! Nance, vague as usual about P3 accrual(but that's a given!)Did indicate that the P3's may not need to be completed..no concrete answers which of course on YMB left open the debate that they are going badly, and that's why they are filing on P2(I don't see this logic)Will be publishing complete P2 data set along with other preclinicals later this year..emphasized that they've found a subpopulation for whom Advexin works quite well..alluded to perhaps future studies targetting this population..whether this will be part of the accelerated approval application plan since the FDA now wants to have solid evidence of trial execution before giving accelerated approvals, etc..??? who really knows..INGN may not know either because these discusssions are ongoing.. They affirmed BLA filing and request for accelerated approval based on P2 data..reiterated the survival #'s in the initial PR.. The YMB'ers have picked up some interesting stuff from the 10-K about this.. Partnering at the 'term sheet level' ASCO presentations of FUS1 end stage lung cancer cohort(9 patients?)..also presenting in INGN 225(vaccine in P1 breast and lung) Otherwise: of note SG Cowen nor Rodman and Renshaw present for call..therefore, no Wall St. represenation They reiterated(assured) that they are with the FDA every step of the Advexin filing process and in Talbot's words, "anything we do is with FDA's blessing.".. I can see how an investor who hasn't followed this company, the field, and management team can be left quite uncomfortable after the CC's..for many reasons, I am not..they are in a hostile environment(within the scientific community, investor and political community) they've been fighting patent infringement, propriety of rights to products/trials(that's why the P2's have taken forever to get because Aventis was muscling them) with the big guys.. The good news on that front is Canji/Schering have stopped p53 clinical work..they'd been a big source of issues...(YMBer found it in their 10-K filings).. Best of luck!...glad they are showing up at ASCO...it hurt them much last year when they just participated in an educational symposium... Zeta

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