FDA Plays

[io_io]

re: AMRN - your response on the BV board to the question, doubting whether the FDA would even approve AMRN_101, is a good one (although I see now that the post you dismiss out of hand is not this one, but dragon's - true he does no DD himself, but he has been known to work hard).

I would add that bio_maven's claim that "the triglyceride reduction was on the anemic side - certainly lower than Lovaza which was around -30% in this population" is total BS because it can be seen here, table on PDF page 8 of the Lovaza review - http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021853s000;%20021654s016_StatR.pdf - that Lovaza had an advantage of 24% or 25% (depending on whether mean or median is used) over placebo in TG. So much for 30%, perhaps bio_maven forgot this was a statin trial. The AMRN_101 numbers in TG are identical for all practical purposes.

Besides, the FDA medical review here - http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021853s000;%20021654s016_MedR.pdf - had no interest whatsoever in the excat size of the TG number - basically the single review issue was the LDL, which made themn doubt any benefit whatsoever. The numbers for LDL are of course just as you posted.