Mark The K Part two, Zonagen's numbers vs Viagra:
1. Forget Vasomax 80 mg results, it is not the intended dose and they have no practical difference from the 40 mg.
2.The 80 mg dose was to prove the lack of serious side effects and if I remember well the FDA ask for it, not originally in the plans, they got what they want it, more stuffy noses but not much more hypotension (for the study population, preselected as per Asensio).
Population was preselected, if poor cardiovascular status, patients were excluded from the studies. Well, this is the ethical thing to do, one does not want to kill patients advertently (Asensio is wrong when he claims it is a shortfall, maybe a longfall?).
3. Two sets of results, The "overall" group including all the patients at 40 mg of Phentolamine 51% erections (75% of the attempts achieving penetration) vs 38% with placebo.
The penetrations in "75% of the attempts" makes the interpretation tougher, to get the 100% success will one decrease 25% the efficacy for both the drug and placebo? ( 75% of 51% is = 38.25% for the drug,
and ( 75% of 38% = 28.5% for placebo) or
(phentolamine 38.25% vs placebo 28.5%) this way is just plain terrible, but IT IS NOT A VALID WAY to decide, because we do not have the whole protocol in the hands.
4.Consider placebo response as 1 time (or 100%), and the drug improvement will be 51%/38% = 1.3 times or only 0.3 times more successful than placebo (or 30% better than placebo).
5. For Viagra: overall " 69% of all attempts successful vs 22% placebo" this is 69%/22% = 3.14 this is 2.14 times better than placebo (or 214% better than placebo).
6. But, the Zonagen's researchers (I. Goldstein) are smart dealing with the public and the FDA, and this is the hidden card, either by design or by a reexamination of the data (I suspect the latter), they found a way, they found "groups" of patients that did better than the "overall" this were the mild group "or the less severe" and in this group: phentolamine 40% vs placebo 15%. Here they could trick even Asensio (I am sure he has no respond for this one). this is an eye popping wow 40%/15% = 2.67 times better or 267% above placebo, this is in the Viagra range of effectiveness ( for the "less severe")category.
I will refer you to the ABTI disaster with their infectious prevention drug Betaglucan, they are trying to present to the FDA the post study re-examined data as an NDA, the market cleverly responded tanking the stock from $12 to $2.
The FDA just does not tolerate "re-examined" data, they know it is easily manipulated, even with good intentions, because the data is already unblinded (not double blind anymore, once the study is open).
The FDA wants the predicted results from the original plans, otherwise is rejection or back to the drawing board, not the post study "re-examinations". That is good to present academic papers in ones' resume, but not for the FDA.
Zonagen's chance is that they originally planned this "less severe" ED population. They could ask the FDA for approval in that population and maybe they have a chance.
If it is re-examine data then back to the drawing board.
Anybody out there has the original protocols?
Caveat # 1: a year ago I was a long for a short period. Since then no position in the stock. Too much uncertainty, too much risk to both sides longs and shorts. I will go in later after the FDA decision.
Caveat # 2: the comparison phentolamine-viagra has a problem, the end points are not exactly known for phentolamine, they are in the New England Journal of Medicine for Viagra. |
