Thursday, April 29, 2021 3:45:10 PM
The same feeling here. If anyone doesn't know- significant FDA part these are the former BIG pharma's workers. It's the same as hiring a herd of goats to guard a vegetable garden with cabbage. I think Genzyme has "representatives" there too. Maybe this is too much, but it seems to me that it all was pre-planned: AA, priority review, facility inspection delay, and full approval for Fabrazyme.This facility constantly produces taliglucerase and pegunigalsidase alfa. There are no issues in this production. Why not check it out with the help of a video? And they can delay checking it for a long time.Full approval for Fabrazyme after many years of AA status at the same time very suspicious at least.My hope for successful completion of the BALANCE study. If the results are good EMA application followed and who knows maybe sales in Europe will start earlier than in the USA.
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