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Re: None

Sunday, 05/07/2017 11:01:02 AM

Sunday, May 07, 2017 11:01:02 AM

Post# of 38634
Possible Delay reasons
1 Accord Healthcare Inc. 400mg do we really know they started shipping this dosage the same time as PAR? Why wouldnt the FDA at least allow the lower dosages?
2 new FDA head required all final approvals to be signed off by him..with other approvals later in the week this doesn't seem plausible
3 FDA never provided the company the official fax of approval so don't think it's a hw/sw issue (unlikely)
4 company owes FDA something outstanding (unlikely)
5 label change on original drug resulting in update of generics before approval
6 FDA is incompetent
7 plant re inspection issue ( unlikely company would have to notify investors
8 other
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