Trevena Inc (TRVN)

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The new FDA guy (Gottlieb) is likely to increase approval odds of Olinvo. Analysts have the odds as overwhelming, but this has been an anxiety for me. The market will price in some chance of rejection. Gottlieb lowers the risk just a tad, as Olinvo is the sort of drug for which there is no safety issue and is used exclusively in clinical settings, where the physician is monitoring use.

The FDA can always reject the drug because of manufacturing issues -- that's a risk we can't shake. I entered PETX as a result of the FDA rejecting their drug because of technical manufacturing issues -- it doesn't change the drug's approval, but it delays market entry by a year.

As many know, Gottlieb has the view that the FDA should focus more on evaluating safety and rely on the private market where there is a gray area regarding efficacy. In our case, neither is an issue, particularly given the extensive studies the company completed, but approval risk is a slight weight on the share price.