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jimmy667

12/29/17 11:45 AM

#135615 RE: kevindenver #135610

All biotech will be supercharged via improved bureaucratic efficiency at the FDA.



I agree. Improved efficiencies at the FDA should help to lower the cost of drug development helping all Biotechs and hopefully end users, the public.

The lower costs will rebalance the playing field by lowering the Cost Barriers to smaller Biotechs so that some of the well-positioned smaller Companies, including Anavex, enjoy a larger boost from the FDA re-vamp.
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nidan7500

12/29/17 11:49 AM

#135616 RE: kevindenver #135610

Kevin...agree and [quoteAll biotech will be supercharged via improved bureaucratic efficiency at the FDA.
][/quote]


I believe the overall risks for investors will be lower in biotech due to the process changes and requirements of precision (prep) medicine. There may be a loss for those who do not even make the PII to III cut. Those trials which formerly might have made the cut to PIII may not w/new process requirements and acceptance criteria. If true we should benefit although it may take a while for this to play out.

At some point a retrospective review of historical big AD losers against new criteria would be interesting. This is going t put a lot of pressure on the FDA, as it should.