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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?

To: Mama Bear who wrote (1601)	1/9/1998 1:40:00 PM
From: F. Jay Abella, III	Respond to of 7041

Not my first post, in fact I wish to revisit the post I made a while back with the stock in the 30's (number 894). The questions I raise, in my opinion, have been answered by the market since mid Nov (with the stock at 32). PS - I am not short the stock, but am only an interested observer. I do think the stock is going lower from here, due to my reading of the white paper only. The company IR, I must say, is top notch and would make a ZONA believer out of most people. However, I think the paper omits some things that a drug developer needs to see. I am not sure if the omissions were uncalculated or intentional. Either way, I do not interpret them positively. 1) for a drug with affinity for a first pass metabolic effect, the paper makes no mention of pharmacokinetics of oral phentolamine. If PK data was not collected or is not provided to FDA, the NDA is dead before it even hits a reviewer's desk. 2) Nowhere is it stated (even in the SEC filings) that the Mexican study was done under Good Clinical Practices (GCP). Under this condition, the data are only acceptible in the NDA safety database. 3) The method of use patent does not cover the oral formulation. Until such patent is released, immense risk in the stock prevails. 4) I'm not even going to comment on the latest from Asensio. I will be formulating additional questions next week. Until then, see a few other questions that I raise in post 894 - (note, they are still unanswered. "PS - If IBD is right, and 100,000 pages of the NDA (times 5 copies) is necessary = 500k pages. That is roughly a 300 volume NDA. How long will this take SGP to perform appropriate statistical analysis, write study reports, integrate each into an ISS and ISE, compile and orchestrate the NDA and submit it to the FDA? Will it be before the 180 day review period for Pfizer is up next spring? Without an equity position in ZONA, and a small upfront payment, does SGP even have the incentive to bust ass to get it done? If the NDA is submitted after PFE's 180 days, will ZONA still get fast track status, or will the application get reviewed at the whim of the Agency? These are the questions I would be asking if I were you all......To me, each indicates LOTS of risk to undertake for a $32 stock. And honestly, who really knows the answers.........I know I don't, and wouldn't care to guess at these levels." FJA