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Biotech / Medical : Immunomedics (IMMU) - moderated
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To: MrChaos who wrote (46009)5/6/2018 1:32:12 PM
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> It doesn't seem to worry anyone.

Right.

In the anticipated order of events, the filing for accelerated approval happens within a month, and the decision is received by year end. Presuming approval, marketing starts immediately, perhaps as soon as December 2018.

And the Phase III ASCENT trial? According to ClinicalTrials.gov, it won't be over until June 2020. clinicaltrials.gov That means that even if it doesn't make its endpoints (which is not likely), Sacituzumab Govitecan will have been on the market for at least two years before the FDA would rescind approval.

In those two years, one might expect SG to develop a following—not only for the label indication of third-line treatment for TNBC, but for off-label uses for other stages and for other cancers. It's politically difficult to rescind approval of a drug that many people believe is a lifesaver if there are no better options and if it's not doing overt harm.

So no, I'm not particularly worried about the outcome of ASCENT. The big gamble is for accelerated approval in the first place.
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