BIOTECH & TECHNOLOGY INVESTING *UNDERVALUED*{T/A F/A & V} Message Board

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Biotech / Medical : BIOTECH & TECHNOLOGY INVESTING *UNDERVALUED*{T/A F/A & V}

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To: CPAMarty who wrote (29)	1/27/1999 9:41:00 AM
From: BRAVEHEART	Read Replies (2) of 423

Hi Marty, I will look at IMCL specifically out of curiosity. Generally speaking one has to determine a products bottom line effect on a company upon the FDA's decision. If a company has a decent pipeline then the effects are minimal. Look at CEPH. Delayed several times but it has held up OK. Why because it's pipeline carried it. Now look at ERGO. Shot it's load. ERGO is all cashed up and nowhere to go. Certainly the product is of key importance. Prior trials and side effect concerns and efficacy are paramount in making a decision to hold or not. Look at ISIP. Approved for an eye condition. Expected in fact. However the Chroans treatments ( the last time I checked ) were having serious bleeding as side effects. ISIP does have a strong pipeline. However it is dependant on a novel treatment ( antisense ). I personally couldn't hold through an FDA decision on Chroans. And I am fascinated by antisense. Just the large molecule presents some difficulties. If and when it is perfected ISIP could easily be a huge success because they essentially have that technology locked up. A nice speculative play on dips for a well diversified portfolio. Other product considerations are in understanding the pathways ( not necessarily knowing ) as Yosi pointed out. Yosi is convinced of PARS as I am of NTII. YOSI argues that the mechanism of action looks highly promising. One should then look to earlier trials for side effect problems. If little or no concerns exist then a hold through the FDA's decision on a next phase or final decision may be weighted more favorably. With NTII and Memantine I believe the pathways and side effect profile issues are favorable for passing P-2. Especially in light of MERZ's successes into P-3 for similar conditions without side effect concerns. Ultimately ones entry point should dictate the risks involved in holding through the FDA decision. If one buys in at say $10 and the FDA will decide at $10 and the company is banking on one product I don't like the odds. ERGO is a perfect example of this. If one buys in at $9 and the FDA decides at $16 and there are other products in the pipeline the odds are more favorable. CEPH is a perfectly good example of this. As far as some answers to your FDA clinical trials check this site it should be enlightening. fda.gov fda.gov fda.gov fda.gov BEST WISHES Jeffrey

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