Any educated guesses on their reasoning? The only logical thing that comes to my mind is that they're negotiating with AMRN. The fact that AMRN replaced CEOs further collaborates my theory (in my own mind). I'm thinking if they didn't want to reinstate it, they would say so on December 20th.
Because the FDA has culpability. "They've been caught with their hand in the cookie jar." As Akanz says, the FDA higher -ups know this, it's rather blatant misuse of Governmental power. The only vehicle that has moved this forward has been the epadruginitiative and Citizens Petition. Hats off to all who have participated in this endeavor. especially those who have led the charge. You know who you are. As an investor thank you for your diligence...
Why FDA delayed ?
IMHO ...actions by Amarin and the Epadruginitiative groups CItizens Petition prompted higher ups at the FDA to reconsider .
Note ...PDUFA Reauthorization . Performance goals and procedures fiscal yr 2013 -2017
Section V11. #5
" Agency will not alter ....etc ...unless public health concerns unrecognized at the time ..etc ...under this process are evident "
The FDA has not identified any health concerns with Vascepa .
The Adcom for Vascepa was supposed to be about whether Vascepa taken with a Statin could lower TG's without raising LDL cholesterol.....the Anchor indication .
It was not supposed to be about whether or not Vascepa reduced heart attacks ...the Reduce it indication.
Instead , Dr Coleman representing the FDA over stepped his mandate IMHO and extrapolated the results of the ACCORD and AIM HIGH trials in a way that was completing inappropriate.
Thanks to Amarin and the Epadruginitiative group ...higher ups at FDA are now well aware of this situation and IMHO are likely to reinstate the SPA.
JMO ....do your own DD ....not recommending anyone buy or sell ...this is a highly speculative situation
I think that they are considering, together with the company, the approval for those younger people not taking statin drugs. This will doulbe at least the potentially patients, rising up the actual weekly scripts around 13000, at the moment. This is enough to ensure 85-90M$/year, ensuring revenues enough to complete the Rit, as both want.