I think that the ANCHOR SPA itself does not contain any reference for R-IT enrollment, it was about study only.
“Now let me just make a few comments about the special protocol assessment. The goal of this process is for the FDA and a company to come to a written agreement on the design, size, and analyses of studies; use, support, and approval of an efficacy claim. And these agreements are considered binding unless it is determined that a substantial scientific issue essential to determining the safety or efficacy of the drug has been identified after the testing has begun.”
and FDA set-up the second criteria with the enrollment requirement
“we told the company that they would, at a minimum, have to provide the division with the results from a 12-week lipid endpoint study, and have a cardiovascular outcomes trial up and running with at least 50 percent of the subjects enrolled.”
sNDA with SPA regulated successful study could not be rejected.
Since they did / do not want to approve the ANCHOR indication they HAVE TO rescind the SPA, since Amarin met with all endpoints in the study and R-IT enrollment exceeded the 50%.
I do not say this is the best management in the world, however based on fact and logic (they submitted the sNDA) FDA did not tell them anything before BD. AdCom was about clinical benefit (while Amarin’s indication was w/o clinical benefit), I could not imagine the label wording / offer that allow Amarin to market ANCHOR, since the FDA (Dr. Roberts) clearly said during the AdCom:
'Finally, in order to approve the indication we are discussing today, we need to be confident that the changes in lipids observed in ANCHOR will translate into cardiovascular benefit.'
Currently Amarin have to focus on further cost decrease, cash management and script number since these elements are “100%” controlled by them, meanwhile try to reach a positive outcome from the current appeal level (OND / Dr. Jenkins).
As I stated earlier this level is the most important:
- it’s the originally targeted level
- the upper level will not overturn this decision
The appeal OFFICIALLY at OND level, however it’s absolutely realistic that Dr. Jenkins discuss it w Hamburg (and Hamburg will decide) just like in a normal business where the Director of Department discuss the issue with CEO (or the CEO put to the Director).
btw: Yahoow shows +0.07 AH, however I could not check the volume, since Nasdaq.com 'Service Unavailable' - due to AMRN Volume ??? :)
UPDATE: '16:44 $ 1.37 High 480,800' !!!???
AI
