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

To: tuck who wrote (701)	3/30/2007 12:03:01 PM
From: zeta1961	Read Replies (1) \| Respond to of 802

Unless they change the rules, INGN has been going thru CBER since this division was created..most likeley Advexin will go thru yesterday's panel(with some changes to include gene-therapy specific panel members) since this was the 'Cellular, Tissue and Gene Therapies Advisory Committee' fda.gov ..I'll do some digging to confirm..I listened to the last hour of yesterdays session after the DNDN vote and they spoke all about the agency's own research in immunology, viral vectors for gene therapy and other cell tissue work..nothing of note as they went into closed session for the 'juice'..current trials discussion. I don't know where Padzur will fit in DNDN or related decisions..we finally have a commissioner..the DNDN bulls think he's got a progressive approach but I don't know enuf to opinionate.. I will say that after watching yesterday's meeting, it felt like a breath of fresh air..science and common sense finding agreement..

To: tuck who wrote (701)	3/30/2007 12:27:50 PM
From: Jibacoa	Read Replies (2) \| Respond to of 802

Yes,we need to propose or nominate Celia Witten,PhD., M.D. as FDA Director.<g> She has stated before that she doesn't want to create a situation where patients cannot get the products that they need and that may benefit them. She was also in the FDA's committee that recommended lifting the silicone breast implants ban in spite of all the trial lawyers stories & theories.<g> Provenge, "failed" on its primary end point in 2 trials, but a "second look" at the data revealed a 4Ms survival benefit in one of them.In the past, advisory panels and the FDA have rejected cancer drugs in similar situations. Do you think that if the FDA approves Provenge on May 15, it could signal a change in FDA's past policy ? RAGL Bernard