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Re: Nanotoday post# 40735

Wednesday, 11/03/2010 2:04:45 AM

Wednesday, November 03, 2010 2:04:45 AM

Post# of 146242
This is how a real company would work, to answer your question:

Day 1: biological target (intervention point) identified
Day 2-92: screening, scaffold and series selection
Day 92-272: SAR, in vitro study
Day 272: lead nomination, intensive in vitro/in vivo studies begin
Day 365: lead nomination confirmed, testing successful
Year 1, Day 1: toxicology center selection begins, CMC/further ADME, pharmacology begins
Y1, Day 60: toxicology center selected, booked for day 90
Y1, Day 90: CMC/ADME complete, toxicology begins
Y1, Day 120: Toxicology complete with no adverse findings, IND writeup begins
Y1, Day 180: IND filed

Best case, with no hiccups, 1.5 years to put a drug into the clinic. Talking $3 million easily. NNVC has never had that kind of money, and barely has it now (assumes no hiccups!). That doesn't include overhead like executives and offices. I suspect they'll never file an IND and just string as much along as they can. Pre-IND is not a stage. It really is just a state of being new to drug development. This is not that complex if you've done it a few times. cGMP, 2 species tox package, ADME optimization, all of this is super-easy to anyone who has done it before (seymour and diwan have not), or who hires any old consultant for nothing, or who has a board of directors. sad little company.
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