Braddock Bull, The FDA says that Phase 3 trials can involve several hundred to several thousand and 25% to 30% and can take from 1 to 4 years. They test for safety, dosage, and effectiveness. As phentolamine has been marketed for many years, there is little doubt that safety is an issue. A new drug application can take as little as two months or up to 7 years, the average being 24 months. I keep hearing people say that vasomax will likely be put on a fast track. I'm not convinced that it will be considered in the "priority" category as other drugs have been approved and will be approved relatively soon.
Part 1. This is long but it hits most of my concerns about vasomax. I am short Zonagen and a novice at this type of investing and frankly very nervous about my position. My fear as the stock started climbing from my short position prompted me to do some more research. The following is strictly amateur stuff. Why I'm short: Sorry if some of this stuff has already been posted. I don't believe that Vasomax is a total scam (as Wexler has posted ad nauseum), however, I think that the valuation of this stock is way too high even now after it has dropped in half. Why? Oral phentolamine has already been proven to be a minimally effective treatment for ED. This has been known for many years. The French and the Italians still use it, but the results are uneven and most are not helped by it. They still use it because the drop out rate for the injection method is tremendous. It is something that may help. The problem I have regarding Vasomax is twofold. First, is this patentable? The Zorgniotti patent had made an improvement over previous methods of administering the drug. If vasomax is as reported, phentolamine with a superdisintegrant, is that sufficiently different or enough of an improvement over the standard phentolamine pill to warrant the granting of a patent? There are many superdisintegrants with similar properties such as sodium starch glycolate or crospovidone. This is pretty standard stuff which gives me serious doubts. Something is not patentable if "the invention was known or used by others in this country or patented or described in a printed publication in this or a foreign country, before the invention therof by the applicant for patent." I would think that this or phentolamine mixed with some other disentegrant or superdisintegrant probably has appeared in some publication given the number of years the drug has been used. Also, "the subject matter sought to be patented must be sufficiently different from what has been used or described before that it may be said to be nonobvious to a person having ordinary skill in the area of technology related to the invention. For example, the substitution of one material for another or changes in size are normally not patentable." Is the substitution of one of the active fillers in the standard phentolamine pill with the one in the vasomax pill sufficient to warrant a new patent. This is of course assuming that the vasomax composition is as reported-I could be totally wrong here. Part 2 coming. Kent |
