First of all, CyDy is over the counter traded on the OTCQB market. Not enough brain energy to research the legitimacy of that exchange, but it is a slightly lesser tier than the OTCQX market as it relates to fiduciary standards, and OTCQX is of a lesser tier than, say NASDAQ. But again, too many irons to fry, this is not one I will spend more time on...
CyDy filed for BTD for TNBC after exactly 1 patient was treated with PRO140, their HIV med-slash coronavirus cure- slash cancer miracle cure.
Taking bashing CMOs with a grain of salt, the CyDy CMO listed on their website was a Spine surgeon from Georgia previously, but still have not reached the press release announcing his departure. The most recent CMO owns a mom and pop clinical trial clinic in San Francisco. I know the type, they get paid to run clinical trials as they are friends with the docs in the area. Dr. Jay runs both HIV & TNBC trials for CyDy, and is suddenly their new CMO to file paperwork for PRO140 in Coronavirus. God help us all, his patients mostly.
Next let's dive into the TNBC data, that ever so compelling BTD worthy stuff of AACR presentations. Right? 1st patient treated with PRO140 and carboplatin achieved stable disease, ie 25% reduction in tumor. Not even a partial response threshold of 30%? That is BTD worthy? I don't think so because it's obviously not clear if PRO140 was the active drug, or if it was carboplatin.
I'm not making this stuff up, head over to their website and you will spend hours reviewing press releases without even making it to when the last CMO spine surgeon hit the road. Apparently many C level execs have been replaced in recent months, but again, cannot find those press releases among the fog of bull.
Getting back to the CMO bashing, in most press releases CyDy quotes the CMO of a diagnostic company who apparently is running all the behind the scenes high tech lab work that the CyDy CEO is so facinated with. After an amazing 6 weeks on PRO140 and carboplatin, no CTCs were found !!! Okay great, what was the methodology, and can those results be repeated after 6 months? The FDA shouldn't be wasting their time with this BTD request until more patients are screened via monotherapy in the salvage setting, in my opinion, but hey, I'm not the CMO of a prestigous OTCQB company.
The 2nd mTNBC patient story on PRO140 is confusing at best, but in the end it sounds like the patient received radiation therapy followed by PRO140 monotherapy and had a 56% reduction of a brain lesion, and stable disease of the primary tumor. Interesting no doubt, but there is so much fishy about this company that I hesistate to conclude without seeing more. On to the other patients...
Patient #3 stopped treatment with not much explanation. Patient #4 had a reduction of blood labs according to that outside CMO's lab tech, but no mention of any other drugs used besides PRO140. Was chemo also used, and could that be why no CTC's found after a stunning 5 weeks of therapy? Give me a break.
Patient #5 CTCs dropped to zero after three weeks. No mention of other drugs used in combo.
I'm sniffing an investigation of this company and the owner going to jail after the FDA figures out these folks are scamming patients. They are definitely scamming investors. Buyer beware.
Oh but maybe it also works in Coronavirus, I actually hope so! |
