Hi everyone. I thought the following post from AOL would be helpful. It is extremely informative and might give one pause before deciding to bail out.
Subj: Latest from Company
Date: 21 May 1997 15:40:25 EDT
From: RSRoig
Message-ID: <19970521194001.PAA04420@ladder02.news.aol.com>
Just had a nice discussion with the company. Enlightening. The obvious first question. When are the results to be released? Patience, it could be as long as 2 weeks. Don't automatically assume it's negative. Facts are it takes time. All the data has to be compiled and reconciled from numerous sites. Also one of the slowest and time consuming aspects is the data from both the patient and partners diaries have to be compiled and reconciled before
unblinding. This wasn't done in Mexico as the partners did not keep diaries. None of the data was available for the C-R forum. They are only halfway through it and have not even reached a point where comparisons can be made to previous studies. They do however feel that they will be in line with the requirements for FDA approval. They have been given the guidelines by the FDA for approval, the exact same which Viagra is using, and they are
confident the results will fit within the guidelines.
The safety issue which was concentrated on in the Mexican trials is satisfactory to the FDA. There is an ongoing dialogue with the FDA.
In discussion involving the German trials, they openly admit it was a set back, but they learned much necessary data on dosing. Each trial led to improvements to the following studies.
After reading continuous concerns from posters about placebo effects, I asked what they felt was an acceptable level for FDA approval. They were less concerned about percentages, although they felt the 50% above placebo they have demonstrated will be adequate. The analysis of the placebo effect is more complicated than just numbers. Due to the nature of the disease, the phsycological aspect cannot be removed. Therefore the actual level of
response and quality will play a large role. When presenting this to the FDA, it will be shown that the quality of the response in drug is much greater than placebo. Enter the MD's, expert in ED, and their parallel studies.They are more patient specific, and can be more selective in who is treated. They are determining what is the most appropriate patient profile for the drug. These studies are VERY positive. The direction of the company is to
determine this profile and educate the physicians prescribing Vasomax. What they do not want to happen is for Vasomax to be prescribed as a "What the heck, its just a pill, try it and see" drug. It could negatively effect the opinions of its effectiveness, which would not be an accurate presentation of the drug.
When asked if a NDA had been filed in Mexico, answer, No. The reason - To file a NDA in Mexico, you must be sponsored by either a national company or one with an existing presence. Zona is still working toward global distribution. The major pharmacuticals are waiting, like you and me, for Phase III results. Another reason to take your time. The company will wait as well, as they want the best deal. There is though, still a national firm still on
board in any event.
I suspect today's weakness is from those getting cold feet. Or taking profits which may be appropriate. I am holding long and will suffer the consequences, good or bad.
Good luck to all, and be patient. Just because they didn't jump to release the results doesn't mean they aren't postive. Lots riding in them!!!!!!!
RSR
Thanks RSR and good luck to all!! |
