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Message: Back to the FDA

To me, the most important date may not be the AHA meeting...it is the FDA meeting.

I think it all comes down to what the FDA tells RVX whenever the two meet in November. 

From the FDA's point of view, the headline risk is gone with RVX: it is safe enough for "chronic drug use".  Then it comes down to efficacy.  Here is where the FDA has wide latitude in what they decide.

Option 1: Yes, this drug is safe and we have more than enough supporting data that is very positive to show efficacy, that it can be sent directly for an NDA.  If that transpires, then a big pharma would immediately buy out RVX; or at the very least Apabetalone as a standalone molecule.  RVX will still need to raise $15 million or so to tide it out but that will not be a problem; only question will be how much equity dilution will be acceptable.  I don't have any expertise in figuring out what the FDA will pronounce.  What I do discern is that the FDA has recently become desperate to approve credible drugs, even if it comes with some warts.  For example, if the FDA can approve that blood thinner Betrixaban (which was a big surprise to the industry), then RVX208 is a no brainer.

 

Option 2: FDA says sorry...we need another x patient years with y MACE events Phase 3 trial.  Given that the data showed RVX208 was safe, starting the trial would be much faster, but we are still looking at at least 2 years before final approval.  Unfortunately, that will require funding for yet another Phase 3 trial...I don't know how much it will cost...say US$100 million.  In that case, a big pharma company would still be willing to write a check or at least partner up with RVX.  However, in this case, the share price won't go up as much as Option 1.  And maybe, the buyout of RVX may not happen.  

A stock price (before the FDA meeting) at any level below say $2 suggests that the market thinks we will get Option 2, IMHO.

Any thoughts?

 

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