RE: FDA approvalSo, making some simple assumptions that yield is doubled, and that the processing train is made up of 3 x 15 liter reactors, and that the turnaround time is 1 week, one can calculate that the new process can produce a minimum of (142 doses per liter x 2 x 15 liters x 3 reactors x 52 weeks) 664,560 doses annually (or 12,780 doses per week).
Even at one weeks worth of production, that's a lot of product just for a few trials enrolling 30 - 50 patients each.
It kind of makes you wonder what the plans are for the rest of it
once upon a time there was a company called synsorb, with a president by the name of Brad Thompson, which built a $20M GMP certified plant with shareholder money to produce two drugs they were developing for ph II & III trials - PK & CD.
hopefully BT has learned a lesson from that, but if he is telling shareholders that the FDA is holding approval up until they have sufficient manufacturing capacity, something doesn't add up.
it seems the focus is being put on the wrong areas again and he is not being forthright with shareholders.
the prosecution rests.
