Dew,
I have read both documents and I no too little details about what infomation GTCB provided the EMEA with, to make a really good assessment. I do however give you my gut feeling and thoughts:
My guess is that the additional questions will not require a new trial. If an extra trial was needed, that would have been clear from the first set of questions already, and at that time there was no indication whatsoever (also judging by the comments GTCB made) that that was the case.
I do however believe that given the small set of data acquired from the trial(s) and the fact that a market approval of a product based on an entirely new production platform is at stake, combined with the new (more stringent) guidelines to be put in place, the EMEA will do everything in its power to address in particular the tiniest safety & quality concerns it can think of.
Also it doesn't help in my opinion that Atryn does not provide a cure for a disease that affects a large group of persons and for which no cure is available. That certainly would have meant more presssure on the shoulders of the EMEA when it comes to an approval.
Instead I believe the EMEA will take all the time it needs to gain knowledge about the particular aspects of this new platform, knowing that there will be a lot more to come in the future. Sadly so it is GTCB who has to take all the hits first.
In conclusion I am very curious about the nature of the new round of questions. I am not so concerned about there being an extra trial necessary (my guess would be less than 10 % chance), but I do believe that it will take GTCB considerable extra time to provide the answers and that approval will not be anywhere near dec 2005 earliest. I do believe GTCB will require additional funding at the expense of the current shareholders and I hope there will be some positive news from GTCB that could lift the shareprice a little before that event will occur.
Regards,
Elmono
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