Teva's comments today about the FDA make no sense. Anyone who has ever dealt w the FDA knows they don't provide you w tacit verbal approval for portions of an application. They never really tell you anything. They ask questions and more questions and move on. You are always open to additional questions, data requests and studies. Then one day you get a letter and you are either approved, denied or need to provide more info.
Complicating the situation for generic enox is the fact that many different divisions of the FDA are involved. The OGD may be totally fine w the drug and then another division, like biologics, can review and ask for all sorts of additional information. In fact, this is what played out several years ago w the request for immunogenicity studies. OGD was fine w the applications and biologics stepped in and requested more work. Word on the street at the time was OGD was ready to approve all 3 of the applications and Amphastar was gearing up for an IPO….looks like that didn’t happen.
The analyst community is shockingly bad.
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