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Re: petergriffin post# 537

Tuesday, 03/09/2010 10:44:55 PM

Tuesday, March 09, 2010 10:44:55 PM

Post# of 27430
Study recruitment. Obviously too slow. Here is a quick synopsis. They rec'd approval from German authority in Oct 07. They apparently did not get first patient in until April or May 08. At every periodic update (done mostly through 10Qs and 10Ks they announced approximately 2-3 patients every three months. As of March 09 they had 10 sites enrolling (up from previous 6). That increased to 12 sites by November. That trend of 2-3 or 4 patients per quarter seems to continue, even though they have doubled the number of sites. Possible reasons: 1. too restrictive entry criteria 2. plain old bad study management 3. patient consent issues 4. lack of interest on the part of investigators, or some combination of these possibilities I don't have a clue as to what the real issue is and management has not really shed much light on this. My opinion is that if this truly were the breakthrough that some believe, this enrollment would not be a problem. Now, I get attacked all the time over at that place we are not allowed to talk about here, but for the record, I actually believe in the technology and I am a big believer in the Docs and bio-engineers at Pitt. I am less of a believer in management of the company. I feel that if the company can get it's act together this could be an effective additional tool in the treatment of sepsis. I do NOT believe it will be a billion dollar product, by virtue of the limitations of adjunctive therapies. The fact is that there are many competing technologies, and generally single medical devices do not garner that kind of revenue potential. This could be a nice, several hundred million dollar product and for a company like this, that should be OK.
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