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It’s tempting to interpret the Food and Drug Administration’s surprise rejections of drugs from Gilead Sciences and Biomarin Pharmaceuticals this week as an agency-wide sentiment downshift, raising concerns that fewer new medicines will reach the market.

Don’t make that mistake.


The overall numbers refute the “FDA is turning conservative” thesis. Through eight months of this year, the FDA has approved 36 new drugs, both small molecules and biologics, according to a tally kept by Ira Loss of Washington Analysis, a regulatory research firm.

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  • Agreed Suze, in the lofty days string of continuous new HIV drugs approvals, Gilead worked closely with the FDA and tweaked the clinical study protocols to optiwhat the FDA was looking for in terms of convincing evidence of efficacy and safety. It seems sadly, the current regime could no longer do that.

  • With certainty, these companies knew at least 3-4 weeks prior to their PDUFA because there would have been radio-silence with respect to labeling discussions and PMRs. So they knew it was going south. In fact look at BioMarins stock price over the 30 days before they got their CRL.

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