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Biotech / Medical : CollaGenex (CGPI) FDA PENDING
CGPI 0.00010000.0%Jul 21 5:00 PM EST
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To: Jeffers Hughes who wrote (17)10/13/1997 6:20:00 PM
From: Tom D   of 142
 
I beg to differ.

I talked with Kevin Tang (the analyst for Alex Brown who covers CGPI) during the Alex Brown Health Sciences conference in May 1997 about the regulatory pathway that CGPI would have to follow. Kevin told me that he thought it was more likely that CGPI would get approval without a DPAC meeting. But he did also say that it could go either way. Imho Periostat isn't really a new entity. We are just dealing with a fancy form of tetracycline here. I am comfortable betting that CGPI's approval will happen without a DPAC approval. What I am not comfortable with is the overall timing of the FDA's approval. CGPI is supposed to meet with the FDA in October to resolve the present differences. When I last talked to IR in September, the date of the meeting had not been scheduled yet. I did sell my CGPI in late September because I can't figure out what is making the FDA unhappy. Supposedly "the way the data is formatted". CGPI got an "approvable" letter. So what gives? My expectation was very high--I expected approval to be a slam dunk. since this is not the case I have decided to take my chances and buy back in when the regulatory timetable is clear--even if this means selling at 11 (which I did) and buying again at 15. With FDA approval this is a $20+ stock. I hope it goes well for you all who are hanging in there.

Best Regards,

Tom D
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