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Re: gestalt2 post# 17057

Friday, 09/01/2017 3:32:28 PM

Friday, September 01, 2017 3:32:28 PM

Post# of 232934
Yes, as that would indicate that everything is going along as normal and we will have our PE results shortly and the BLA application should proceed as normal sometime in the late Spring/ early Summer of 2018. The fact the company had to send out a PR about meeting with the company indicates there is something going on that is not normal. It may be something positive is happening, but I think there might have been more hints about that in their PR's if it were the case. When we see now that the trial protocol has been changed, that only raises more questions. None of which have any clear answers. So, I would definitely be happier about PRO 140 if its test were simply proceeding in a normal fashion without the need for consultations with the FDA about how to analyze the data. That is a big red flag.
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