FDA questions efficacy of testosterone and whether risks really do exist, page-10

Thanks for that MarkieMills,

I'm looking into purchasing ACR and I've just finished reading the first 30 odd pages of the brief for the FDA's upcoming meeting on Sep 19. I really had two major questions that kept popping up which holders might like to consider and enlighten me on if they knew the answer to them.

Firstly, the question most pressing to me is why were these studies conducted on patients who have underlying cardiovascular disorders? Quoting page 31: "These studies demonstrate that men who receive TRT are more likely to have underlying comorbidities. This observation is corroborated by DEPI’s concurrency analysis which showed that over one-half of men prescribed TRT were receiving concurrent prescriptions for cardiovascular medication".

What i'm trying to get at here is, wouldn't the presence of a pre-existing cardiovascular disease skew the results and provided a biased conclusion? The last section of this part ends with: "Additional studies, either clinical trial or epidemiological data, using data sources able to capture important baseline and time-varying characteristics including the diagnosis for TRT use, cardiovascular risk factors, and laboratory results are needed to better characterize the cardiovascular risks and benefits of TRT".

The next pressing issue i see in the FDA's concerns is the effectiveness of this treatment - this is a major issue which i believe they will be testing rigorously. If it can be proven again that treatments such as Axiron do indeed increase testosterone levels in patients, i believe Acrux would receive the all clear from the FDA. A major question here is though, wouldn't the effectiveness of Axiron have already been proven prior to its release?

It is highly possible that the FDA comes to the conclusion that Axiron is not safe for patients with pre-existing heart conditions or cardiovascular issues. This would reduce the sales of Axiron to some extent, by how much it isn't known yet. The next possibility is that the results are inconclusive, the other of course if they decide by some time next year that the product has a considerable risk compared to the benefits provided, however IMO i do not consider this decision highly likely. Testosterone injections have been approved for medical use since the 1950's, why haven't they been banned in the 60 years they've been in use for?

With regards to the efficacy of the drug, perhaps next time one of ACR's holders are at the GP, ask them - How effective is Transderman Testosterone Replacement Therapy in your opinion? Would you prescribe it to your patients? How have the results been from your previous experience in using them? Next, if anybody knew the primary markets Axiron was being sold in, would they possibly be able to reply to this thread? I remember seeing Switzerland as a major market for Axiron, but maybe i'm getting this mixed up with another company!

Nonethless, it was very encouraging to see strong Q4 14 sales for Axiron - an encouraging sign indeed. It really makes me wonder, if the FDA released its concerns last year, how much of an impact will it have on ACR's sales if sales came in stronger in Q4?