So, I just got off the Pozen conference call about the Trexima delay (by the way, it won't be called Trexima if/when it comes to market, as the FDAis asking Glaxo for a name change. The agency sometimes does this if, for example, it believes the name looks or sounds too much like an existing drug and could confuse pharmacists.)
Anyway, the company says the FDA no longer has an issue with the potential cardiovascular side effect of the migraine pill. Now the agency is apparently worried about carcinogenicity that was seen in an early study on Chinese Hamster ovaries. The critters were given--according to Pozen Chairman and CEO John Plachetka--a megadose of Trexima (about a hundred times the amount what a human would take) and it killed cells.
This means Pozen may have to do a small study on people. But Plachetka says experts the company has already talked to think it's an anomaly. Nonetheless, the additional study could delay approval of Trexima at least a few more months.
Plachetka thinks they can do the test very quickly and said that Pozen would lobby the FDA hard to hurry up and look at the data. He said it's the type of data that a scientific reviewer could process in an hour.
During the Q and A period on the call, Jefferies & Company analyst, Eun Yang, said the FDA is "nit picking".
Plachetka made repeated references to the FDA's cautiousness these days. He said, "We all know it's a difficult regulatory environment. We see examples of it every day. Given where the agency is today they might wanna be in a position to say, 'Yeah, we ran it (the Chinese Hamster issue) down'."
Today, investors are running down Pozen shares, but it will be interesting to see if Plachetka's optimism on the call regarding an accelerated timeline helps minimize the damage.
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