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Biotech / Medical : T/FIF, a New Plateau -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (1241)	7/3/2002 11:53:46 PM
From: Biomaven	Read Replies (1) \| Respond to of 2243

The SEPR story (which seems believable) is that the FDA didn't raise the long-half-life QTc interaction with them at all during the application process, although they had extensive discussions on the QTc issue along the way. Their feeling is that the FDA didn't focus on this issue until after the NDA was submitted. The FDA request to SEPR is not at all unreasonable on its face, but it was hard to predict ahead of time given that it was literally unprecedented - nobody has ever had to do a long-term QTc study before. So I don't see SEPR as having run through any stop signs (or even any yield signs <g>) - rather they just weren't proactive enough in thinking through some tricky issues ahead of time and they incorrectly assumed the FDA would do their safety thinking for them. BTW, as evidence that the safety bar has indeed been raised, just look at this list of approved drugs with QTc issues: torsades.org I wonder how many would get approved today based on the original studies? Peter