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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI -- Ignore unavailable to you. Want to Upgrade?


To: Peter V who wrote (4246)7/20/1998 1:53:00 PM
From: Dixie7777  Read Replies (1) | Respond to of 5736
 
As you have just "phrased" it, not much. In context of the attendant PR's and informational intent by all parties to the PR, a world of difference.

Make your calls, or are you also physically challenged?



To: Peter V who wrote (4246)7/20/1998 3:26:00 PM
From: Cacaito  Read Replies (3) | Respond to of 5736
 
Peter V, the way I interpret Maisels,s opinion, especially with the
Nelcor pulse oximeter comparison: the "multicenter" studies will be done
and many of this studies will not be by the company but buy independent
clinicians to prove the value of the new device .It is done with every
single new drug and device, and many wait for this non company study
to buy the product.

That the company (or Maisels on his own) conduct post-marketing
studies is not rare, some areas of applications were probably not
covered initially ( for example: very small premature babies, or
infants older than 2 weeks).

Look at today's news on Genentech drug for strokes (it is proven
within 3 hours to be beneficial) they were trying to prove the same
after 3 hours (it will double or triple the market) and it did not work.

The "multicenter" studies Maisels referred to will not be needed for the
initial selling of the device (if the marketing partner comes around),
they are already approved, they only need the buyers, not more studies.