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Biotech / Medical : Life Medical Sciences (CHAI) for Hair Regrowth? -- Ignore unavailable to you. Want to Upgrade?


To: Art Odell who wrote (1114)2/6/2000 8:15:00 AM
From: Gregory Messenger  Respond to of 1152
 
Art

That is my understanding as well.



To: Art Odell who wrote (1114)2/6/2000 9:16:00 AM
From: GregSL  Read Replies (1) | Respond to of 1152
 
Greg and Art-

How much experience do you have with biotechs and the FDA? I have never heard of a drug being approved after one clinical trial. Very rarely a drug may get accelerated approval after a Phase II trial. That only happens when it is a treatment for a serious life threatening illness. Repel CV would not qualify for that consideration.

A Phase I trial is only meant to show safety in humans. Sometimes you can get a hint of efficacy, but there have been many drugs that looked good in Phase I only to be a bust in Phase II and III.

Here is an idea of the time involved after Phase I. Phase II is one to two years. LCBM's Phase III was started in April 96. Patient enrollment was closed in November 98. Data analysis was completed in March 99 and the PMA was filed in May 99.

Using a similar timeline, if all goes well Repel CV is at least 5 years away from approval. Because of the type of surgery involved, I would expect a Repel CV Phase III trial to take longer with a longer period of follow-up for data collection.

I am doing my DD on CHAI. The price seems reasonable for a company with one drug in Phase I. The recent run-up in the price may be in anticipation of the Phase I results being reported. What do you think of management? What is the burn rate? I see they have $700K in cash. That is not enough to take a drug through Phase III. Do they have any financing?

BTW - the link to Allen and Caron is no longer active and they do not list Life Medical as a client. If anybody still has a copy of their report, please email it to me.

Greg



To: Art Odell who wrote (1114)2/8/2000 11:29:00 AM
From: Marc D.  Respond to of 1152
 
Art,

Yes, it's my recollection that it's a two stage process, but I'll go back and read through the research I have.

-M