Biotech Values

[urche]

>>I think the chances of EMEA requesting a new study are <25%.<<

What would your guess be?
You are merciless in your pursuit of numbers, DEW. I say 10%, mostly because it would seem unprofessional to ask for a new study at this point. Their proper opportunity for that would have been with the first round of questions.


>>But, I think there is higher chance that some EMEA commisioners want to know how soon the US ATryn could be completed and are going to ask for feasibility or outright demand that approval be deferred until after that study.<<

I know this sounds like it contradicts what I just said. But, I try to put myself in the shoes of an EMEA commissioner facing this decision regarding the world's first approval of a transgenic therapeutic protein. Around the table are some arguments pro and against immediate approval. Then information is made public that GTCB plans to do a very similar study this year to suit the FDA. Wouldn't it be understandable for this commissioner to at least ask for details on that study and perhaps take the expedient position that this decision should be postponed until the US study is completed?