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Re: DewDiligence post# 24592

Monday, 02/27/2006 2:01:01 AM

Monday, February 27, 2006 2:01:01 AM

Post# of 257295
GTCB thoughts/politics

“It’s easy for people to say that the whole two-year review process was BS and the application never had a chance to be approved for political reasons. I respectfully disagree. With more patients and no alteration in the dosing protocol, I think the application would have breezed through, politics and all.”

I agree that things are not black and white, but IMHO GTCB is handicapped by the political aspects of transgenics, peppered with a bit of xenophobia. If anything goes wrong down the road with Atryn or subsequent drugs in this arena, the CHMP may want to have bullet-proof data to fall back on. If GTCB had bullet-proof data, things may indeed have turned out differently… but, on the other hand, if Atryn were derived from cultured milk glands (hypothetically speaking), the level of scrutiny might have been lower and the CHMP opinion may have fallen on the positive side. Thursday, I think GTCB investors saw (unfairly) a higher level of scrutiny applied for this novel (and fear-provoking for some) technology. CHMP or the EMEA ought to acknowledge this if indeed it is the case. Otherwise, it appears that GTCB management does not run a tight ship. Either way, it doesn't look very appealing.

On another note, this article may possibly be of interest: Post secretional modification? (sorry, I don’t have access to the article).
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_...


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