Biotech Values

[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