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RPRX Type 2 Diabetes Ploy: Cherry Picking Data

|Includes: Repros Therapeutics Inc. (RPRX)

In order for RPRX to continue their existence, they place themselves at the forefront of biotech research in the development of treatments for huge markets. RPRX does not present data in an acceptable scientific format. They consistently present data in bits-and-pieces that advance their self-serving purposes, not those of science, patients, or shareholders. 

The proof of this argument lay in the claim by RPRX to file an Androxal IND for type 2 diabetes. This is the “smoking gun” to their shell game. Still, to this day, RPRX has not proffered an argument or reference that supports the use of Androxal for type 2 diabetes, other than the testosterone rise with Androxal administration. However, RPRX has repeatedly said that the blood glucose change did not occur with AndroGel administration. Despite this fact, many RPRX longs continue to hold fast to this MOA as a rise in testosterone levels. 

Disregarding the absurd and ridiculous notion of testosterone administration for type 2 diabetes, I suspected that the RPRX data supporting some other mechanism of action for the blood glucose changes was flawed. RPRX knew very well that any MOA based on a rise in testosterone for type 2 diabetes was DOA. 

But, what was most troubling is the RPRX finding for blood glucose changes with Androxal administration and not AndroGel administration. The literature is clear for positive effects of testosterone administration on glycemic indices in type 2 diabetic hypogonadal men. Where is the disconnect? This has to be found within the RPRX population study. 

The RPRX presentations only disclose the blood glucose changes, but not the details of the study group. The strongest suspicion about the RPRX study is the men are hypogonadal, not type 2 diabetics. This led me to believe the study groups had significant differences in the baseline blood glucose. If the blood glucose level of the AndroGel study group was significantly lower than the Androxal study group, the expectation is to observe no blood glucose change. This is the case. 

RPRX cherry picked data to ensure a change not seen with AndroGel administration. Nowhere in the RPRX presentations, PR, and webcasts does RPRX reveal the baseline blood glucose. RPRX screwed up! I have found confirmation/proof that RPRX is cherry picking data for their own fraudulent means. 

I found the smoking gun. RPRX filed a USPTO application where they reveal the baseline blood glucose. The Androxal study group has a baseline blood glucose 15% higher than the AndroGel study group. The mean blood glucose in the Androxal group is 140. That in the AndroGel and Placebo group is 120. The World Health Organization definition of diabetes is for a single raised glucose reading with symptoms, otherwise raised values on two occasions, of a fasting plasma glucose >/= 126 mg/dl. http://www.who.int/diabetes/publications/en/ 

RPRX not only picked a sub-subpopulation, they went out of their way to have these cherry picked subgroups to have significantly different baseline measurements. They did not reveal the differences, but instead, went so far as to promote and perpetuate this “finding” within their SEC filings, presentations, website, and PR as unique for Androxal. 

Why did RPRX fail to reveal this in their presentations? The answer is clear. If the recent PR contradictions serve as a basis for a class action lawsuit, this newest revelation demonstrates the extent that RPRX goes to further their deception. Enough is enough, these shell games need to end. 

Also, the RPRX USPTO application makes the following claims [Note they do not claim to treat type 2 diabetes, but a blood glucose between 125-140 in hypogonadal men. This shows a complete disconnect between the facts and their proposed IND.]: 

24. A method for reducing fasting glucose levels in a subject with secondary or idiopathic hypogonadotrophic hypogonadism comprising administering to the subject an effective amount of a composition comprising an antiestrogen. 

27. The method of claim 25, wherein the subject has a fasting glucose level between 125 and 140 mg/dl prior to said administration. 


http://www.faqs.org/patents/app/20090099265 

http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=/netahtml/PTO/search-bool.html&r=2&f=G&l=50&co1=AND&d=PG01&s1=repros&OS=repros&RS=repros 
http://portal.uspto.gov/external/portal/home