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Message: Re: FDA validation.....

Cancun ... been trying to wrap my head around that also. The point of P3 was to hit endpoints, proceed to NDA right? ... pass go, collect $200 (or more).

With BT status, we may still have some "validating" to do with studies or at least some additional data thru bolt-on though right? ... not clear on this part?

If BT status were a path to NDA right now, then I would say it is as good or better than than P3 success, as it would accomplish the same thing, with a positive view of apabetalone being expressed by the FDA, by definition of BT status? ... especially following a P3 shortfall?

Still need to learn of next steps ... but a great great day!! ... I think this favorable FDA position puts a lot of pressure on BPs that have been in discussion, and perhaps competing for apabetalone and the epi-genetics leadership position for the next few decades.

RVX is only going to get more expensive, going forward, as we get further down the tracks. And we are back on the tracks, after the September derailment. Let's pick up some additional (and EXPENSIVE) steam hopefully after hearing from the Euros and Asia next, and hopefully excellent CKD data in March!

 

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