Replies to post #9029 on Biotech Values

[DewDiligence]

PGS re GTCB: I think you and I are on the same wavelength:

>>
Re: Two balls and no strikes.(DEW)..
by: DewDiligence
03/04/05 11:28 am
Msg: 18005 of 18216

>>…what could possibly still go wrong in Europe knowing they have followed the EMEA guidance document for ATIII, 2 more patients were treated than required and efficacy/safety was conform the ATIII from plasma?<<

1. The two cases of suspected (non-clinical) DVT. Not likely to be a problem, but possible. [3/17/05 note: this is my "25% case."]

2. Product-characterization issues. [3/17/05 note: this is my "75% case."]

3. Murphy’s Law.

Posted as a reply to: Msg 18004 by mblimon2000
<<

[rstor1]

PGS - Multi-jurisdictional delays.

I'm not suggestign that the viral vs protein risks are comparable. I am suggesting that CYA concerns can delay drugs filed in multiple juridictions.

FWIW, the FDA position on the virus was absurd, since the population to be studied was salvage pts, with a few months to live, if that. I would think that delaying a dose escalation study by 3 yrs in a population with no recourse borders on the negligent.

Perhaps the EMEA comissioners are more comfortable delaying until they can point to pts enrolled in the US clinical. I don't think it's an absurd idea, even though it is not necessarily rational.

Regards,
Bob