At one time, GTHP had a pretty good shot at getting FDA clearance, but when the FDA rejected them for the third time in 2014 it pretty much killed this company.
Good things might still happen -- the patent still has enough time left -- but the company needs funding for a US trial and they seem unable to get funding.
I keep wondering out loud about the CFDA submission. What clinical evidence is Shandong supposedly submitting to the CFDA? When did they submit their application for clearance -- DID THEY EVEN SUBMIT AN APPLICATION YET?
Gene-o knows what the FDA wants for US clearance. What a perfect opportunity to have the Chinese structure their clinical protocol to meet the US FDA's request, and then use that trial to submit a new 510(k) to the US FDA without paying for new clinicals. But the lack of disclosure makes me think Shandong never ran any new clinicals. That means Shandong did, or will, submit GTHP's old clinical evidence -- the same crap the US FDA rejected. Not good.
Incidentally, Gene-o isn't the failed and incompetent CEO who botched the three 510(k)'s that got rejected -- Gene came in after that 3rd rejection. Can't blame Gene -- he's doing what he can to keep the doors open. Unfortunately, that means toxic financing.
Gene release hype PR's occasionally, but when there's no real news, what can the guy do?
on a positive note -- the sub-penny pinkie biotech stocks that suddenly increase 1000% or more are companies just like GTHP, where everyone with a lick of sense has long ago walked away. There is a slight chance that the China Hype isn't just Hype. Maybe there's no disclosure about Shandong's plans and actions because Shandong is keeping their cards close to their vest....
And maybe I'll win Publisher's Clearinghouse tomorrow.
Is that still a thing? Does that reference show my age? :)
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