Biotech Values

[hptaxis]

RPRX "PumP" Podolski PR

"Pump" Podolski recently put our a PR touting the success of Androxal (below). Well, by this time all should be looking for what is unsaid rather than what is said.

It is finally very clear that approval is based on fertility and NOT TT as "PumP put out on numerous occasions over the past years. The FDA shut this down long ago, but that didn't stop PumP.

Another piece of misinformation put out by PumP over the years was how those on topical TRT were just plain infertile. He declared that they weren't just minus some sperm, but outright demolished. Why he even put out PRs stating as much.

It is clearly seen by the TRT literature which shows a roughly 50% might be infertile. But, more so, common sense says this was not true or it would have been all over the news that TRT was also as good as a male contraceptive.

I was sure if he ever maintained that stance, he would be quickly found out to be committing data fraud. Anyone familiar with PumP knows he is an expert as misinformation and misrepresentation (lies).

The PR declares that BOTH co-primary endpoints were reached. BUT, PumP doesn't mention that THIRD co-primary endpoint. "Percentage of men that exhibit sperm = 10 million/mL at the end of 16 weeks of dosing and testosterone in the normal range, comparing Androxal®to a testosterone gel as well as comparing Androxal® to placebo." http://ir.reprosrx.com/releasedetail.cfm?ReleaseID=860148

Anyway, my point is the PR shows the sperm count on TRT to be 45 MILLION. FERTILE!!! They are fertile by WHO standards. REALLY REALLY FERTILE.

So, it will come down to how the FDA approaches the data. It makes me very suspicious the FDA would pass on a % change when it means nothing clinically. I mean NADA/ZIP/ZERO.

Then, there is the absence of QoL data. SERMs are a very poor "TRT." It is a rare male that chooses a SERM for TRT. SERMs are currently available in many forms - Clomiphene, Tamoxifen, Raloxifene - and are basically NOT used. Androxal is the trans-isomer of Clomiphene. This is to bring out the point that even if the FDA approved Androxal, which I doubt, the market is absent.

They could find utility in restoring HPTA function after stopping TRT or non-prescription AAS. Here, they would be used short term. But, that is not the IND. There is the problem of SERMs already available.

In the past, I wrote many times about PumP over at the RPRX Board, including the SPRM (Proellex) demise. Androxal will eventually suffer a similar fate, but not before PumP can use the RPRX ATM to exhaustion.


Androxal(R) Achieves Superiority in Top Line Analysis for Both Co-Primary Endpoints and Various Secondary Endpoints Versus Marketed Topical Gel in First of Two Identical Studies in the Treatment of Secondary Hypogonadism
http://ir.reprosrx.com/releasedetail.cfm?ReleaseID=868068