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Thero did not jump the gun. He simply

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Atom0aks   Wednesday, 08/14/19 01:55:48 PM
Re: marzan post# 208802
Post # of 210649 
Thero did not jump the gun. He simply reported the facts as he received it, most likely for the sake of transparency.

According to Thero, the FDA asked that he wait until they filed a notice with the Federal Register. Based on previous AdComs, this filing can occur as late as a month before the meeting. The AdCom is predicted to occur in November, therefore waiting until the FDA files in October to announce an AdCom would be well beyond the PDUFA action date in September. Thus it makes sense that once Thero was advised an Adcom would occur after the PDUFA action date, he safely assumed that meant the PDUFA action date was going to be extended and so had no reason to wait for the official filing.

Also, I would like to point out that the AdCom is predicted to be conducted by the Endocrine and Metabolic committee. This most likely means that the label is encompassing patients with cardiovascular risk as a sequela to dyslipidemia, and not a wide open label as many are speculating.

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