Jim --
I work for a major pharma, and I've been involved in a reasonable number of NDA filings. (Integrity note: I am not involved in direct discussions with FDA on anything which directly competes with BTIM).
First of all, your view that the ABT relationship somehow constitutes an endorsement of BTIM is contrary to all facts. Every major pharma understands the probability of success for their compounds, and accordingly enters into many relationships with companies whose real likelihood of success is fair to poor.
Second, the studies quoted were (it seems to me, deliberately) powered to show equivalence, not superiority, to anything currently on the market. Accordingly, BTIM will have to do additional studies to prove anything for any commercial or regulatory purpose. Meanwhile, since ABT already owns the reference product, why would they promote BTIM's instead?
Third, the key parties in BTIM appear not to have come to the party with clean hands. Their previous company blew up in the context of very serious questions.
Jim, it is my view that you are probably a paid influencer for BTIM. If that is the case, I would strongly suggest that you add that disclaimer to the postings you make in favor of this over-hyped company. |
