Algernon's Leading Compounds (drugs) will be those that already passed Phase I, II, III of a clinical trial somewhere on planet earth. The drugs were found to be safe for Humans in whatever dosages prescribed. The FDA has mutual cooperation agreements with nation's around the world. Where it's a given that clinical trials conducted outside of the US is treated just the same. Now here's my Crystal Ball Theory: It's my belief there is absolutely no question our Lead Compounds will start @ Phase II - Period. Not a...well we couldn't make it happen. The countries that management targeted for our drugs are Russia, Ukraine, and Japan. I do not see them listed at FDA under a cooperation agreements. However, I would have to believe management having clinically targeted those countries understands what requirements are necessary to fit the bill with FDA. Meaning, management will present the previous clinical trial paperwork along with thier own preclinical findings in a package to FDA. Management also told us about targeting off-label drugs to eliminate hurdles to getting after the money. All of what I just said falls into the reasonable minds category. However, here's my actual Crysta Ball Theory: When I see Russia, Ukraine, and Japan, the first thing that comes to mind is the Trump Administration. Trump's administration is all about the money. Front door. Backdoor. Side door. Rules...who needs rules? Regulations...who needs regulations? Laws...what laws...I don't see no stinking laws. Planes falling out of the sky...what planes falling out of the sky? The rest of the world grounds crashing planes. POTUS says F*** The World! So yeah...I think we're all good on the lil FDA thingamajig. At least for the next 2 years. We may all be somewhere vacationing half way around the world by that time. Maybe Russia, Ukraine, Japan?
My how time flies...gotta run.
Peace,
/////AMG
P.S. Our CSO, Mark Williams, isn't only a Doctor with 12 years of Clinical trial experience. He also has an MBA. I think he knows what he's doing. Plus, Renmark Financial will put more meat on the bone as time moves forward.
