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Biotech / Medical : BIOTECH & TECHNOLOGY INVESTING *UNDERVALUED*{T/A F/A & V} -- Ignore unavailable to you. Want to Upgrade?

To: Larry Liebman who wrote (16)	1/16/1999 10:23:00 AM
From: yosi s	Respond to of 423

SKIPPED phase 2 Companies may design a study that phase 2 is included in phase 3. It speeds up the process,but increases risk. ie. if things did not work phase 3 is more involve more patients etc, thus more expensive. Also phase 2 is a part of a learning curve, may helps design a better model for phase 3.

To: Larry Liebman who wrote (16)	1/16/1999 12:22:00 PM
From: BRAVEHEART	Read Replies (2) \| Respond to of 423

Hi Larry, Good question. I believe those which offer the highest degree of success with this approach are products which are already approved for other indications. Products which have known pathways. Products which already have a treatment history. I seriously discount new novel therapeutics which attempt this approach unless earlier clinicals are extremely successful for efficacy with little or no side effect profile. It seems like the FDA has a bent for knowing the actual mechanism of action. CYPB comes to mind with their trials which were halted because of the success achieved with their product {mechanism of action ( device? )}. NTII may take this P1-P2 NDA approach with Memantine for the treatment of Aids related Dementia. The product fit's my model of pursuing this avenue. Memantine has a 10 year treatment history for dementia in Europe. This removes side effect risks & offers evidence ( MERZ's massive P-3 data ) for success for very similar indications involving the NMDA receptor for the same product. NTI's earlier clinicals also suggest the indication is being treated with great success. Larry I am not familiar with SUGN. Did they jump from P-1 to P-3. What were the circumstances surrounding this achievement? Is the therapy novel? BEST WISHES Jeffrey