Oh yeah!
Or maybe if they have a sunny days or wife / girlfriend was nice with them they will approve R-IT now w/o result and sNDA ...
Meanwhile, It's normal that AMRN is in our focus - it's AMRN board - it's just one drug for the FDA. They are not people, they are office: no emotion, no logic.
No question, they were wrong w SPA rescission and I think that they were wrong w NME. However, these were not decided based on emotion or corruption. The situation is worst. They were wrong.
NCE will be decided by the court and it won't affect anyway - nor legally, nor emotionally - the SPA / sNDA.
SPA: I do not expect the reversal. Maybe the Committed will say that FDA was wrong technically (timing), but they won't reverse the decision itself.
sNDA: I see a good chance for ANCHOR's data on label - as best case scenario - but nothing for approval. meanwhile a lot of study support it, none of them confirmed. That's it. FDA did not say it isn't effective, they said: we do not know and it's not an AA.
Don't expect a miracle, a short-term solution. It's 16 months ahead. During this we have to see: increase in script#. Depends on this increase AMRN could reach the interim result w/o external financing.
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