Re: Back to the FDA
in response to
by
posted on
Oct 03, 2019 10:15PM
Bear,
this is not about actually filing an NDA.
This is about what the FDA thinks of the results of BETOnMACE. The opinion expressed by the FDA will be sufficient for a buyer of RVX to figure out how long it will take them to bring Apabetalone to the market, the risks and the payoffs associated with it.
For Pfizer the main issue is how quickly it can bring Apabetalone to the market. Managing the FDA is easy, once Pfizer has a good idea of how the FDA is tilting. Option 1 (FDA saying they are fine with a clear path to NDA) would be easy for Pfizer to manage as they have enough in roads into the FDA process and can accelerate the final approval process (once the initial opinion is known). Option 2 (additional x patient years and y MACE) is also acceptable, but it will delay the whole time to market by 2 years, and add some more complexity.
In either case, the data (which I assume RVX is sharing with potential buyers) and the FDA opinion is all that will matter.
As the Makalu report suggested, RVX208 has startling parallels to Humira, and any buyer would recognize that. Abbott paid $300 million for Humira...and last year sold $18 billion. Apabetalone will be simiar, IMHO. Would you not buy it asap, like Abbott did for Humira?
In either case, the FDA's opinion is vital in convincing some like Pfizer to buy out RVX.