HD: Thanks for your note. I was part of EPADI, and following
ADCOM, I volunteered to contact Waxman. I had been his Constituent
for over 25 years (living in Beverly Hills). I had personally
contributed to his campaigns, and actually had several conversations with him over the years. I was impressed by his signature 1997 Hatch/Waxman legislation, which ostensibly had
the purpose of leveling the playing field for Small Biotech vs
Large Pharma. It accelerated the approval process, put in place
PDUFA fees, and created the SPA. Since he knew I was a constituent, getting to him was easy. I initially crafted a letter
exposing the ADCOM Sham, and IMO breeching his legislation by
negating the Anchor SPA. He was receptive and we had several
interactions. After he became involved, the SPA was eventually
put back on the table. Epadi, Zum, Go Seek and others told me that
John Thero had acknowledged that his involvement along with Senator Chuck Grassley (who I also luckily got in touch with) was
very helpful in getting the SPA put back on the table. That's
exactly how it came down. What happened MLK weekend, was that after 3 days of negotiating ( FDA and Thero and AMRN'S CMO) the
FDA pulled the plug. There were quite a few HF's involved and the
story that I heard was that FDA wanted to revise the SPA, and AMRN
didn't agree. As to the compromise, that was just Wall Street chatter. It was published in an Industry Publication, and the word
spread. Unfortunately retail investors don't have the same access
to information that the Investment Community does. Someone always knows something we don't know.
