Replies to post #170385 on Biotech Values

[gdollasign]

So how can Ariad and FDA come to such different conclusions as to what represents AEs?

That is part of the case here, is it not?

Seems the CHMP opinion sees it through Ariad's eyes per the release today.

[DewDiligence]

Apart from bona fide differences in opinion about the risk/benefit tradeoff, the EMA is apt to be less concerned than the FDA was about “inappropriate” sales in the second-line setting. In the EU, such sales simply won’t happen because they won’t be reimbursed.

[jq1234]

Yes. FDA digs through the datasets much deeper. They already did in original label, see my previous posting on hypertension as AE, huge discrepancy between label and presentations. It is going to take some time IF FDA decides to revise label, put REMS together. Remember for NDA resubmission for example, REMS is class II response, 6-month.