This is what I posted on the YMB.
Delay in SPA Decision is Very Positive
Contrary to what many shorts believed, the FDA is taking the decision to reinstate the ANCHOR SPA very seriously. If the decision was already made not to reinstate the ANCHOR SPA as the shorts have contended, this would have been announced today without any further delay. This would have been an easy decision.
However, it now appears that the FDA is ready to reinstate the SPA and negotiating with Amarin regarding the the ANCHOR sNDA approval; and in what form that will take place. Most likely, ANCHOR sNDA will come with some restriction (whether boxed warning or regular warning) cautioning about the lack of cardiac outcome study and possibly conditional approval linked to REDUCE-IT outcome results.
If they were not close to a final compromise, the delay in the FDA decision would most likely have been announced earlier in the week- not at the last moment. To this point, PR stated "based on dialogue with DMEP, Amarin does not expect the delay to be for a significant period of time." Any way, I see the delay as a very positive development.
IMV, the FDA would not have delayed the decision twice if they did not intend to reinstate the ANCHOR SPA and approve the sNDA- it appears that there will be a compromise that would best serve the patients with high TG levels and address FDA concern. I believe the final approval will come with either a warning regarding lack of cardiac outcome data, conditional approval linked to REDUCE-IT data, or limited approval to a sub-population of high TG patients with low HDL. The approval is likely to come sooner than later.
GLTALs.
Speedrunner
