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Thursday, 02/22/2024 11:22:14 AM

Thursday, February 22, 2024 11:22:14 AM

Post# of 15565
History of GTHP for new investors - a primer

Of course, everyone does their own exhaustive DD before they buy a stock, but if any new investors want the Cliff notes:

GTHP got their 3rd FDA rejection in April 2015. Here's the PR:
https://www.otcmarkets.com/stock/GTHP/news/FDA-Completes-Review-of-Guided-Therapeutics-LuViva-Advanced-Cervical-Scan-PMA-Application?id=105061

The PR doesn't seem all that negative as FDA rejections go, but this rejection caught GTHP by surprise. Plan A was to get the PMA approval and get financing, so when the PMA was rejected they had no money and no plan B. The company fell into toxic death spiral financing with a couple of VERY shady lenders (One of which got into trouble with the SEC and caused them to dump in June 2023 but that's a different story). There was a 1:100 R/S in Feb 2016 and when the PPS tanked there was another R/S, this time 1:800, in 11/2016, but the PPS tanked even harder after that second R/S.

The company had no money and frankly not much hope of surviving, but somehow, Cartwright the CEO managed to get rid of the toxic lenders over the next few years. The company re-established communication with the FDA in 07/2017 and when they did the most recent R/S in March 2019, the resulting PPS of 15 cents has held.

They managed to get funding for a new clinical study, and it's coming to completion:
https://clinicaltrials.gov/study/NCT04915495

Notice I didn't mention SMI. I will believe the China Hype when GTHP gets a sizable check. If you read all the China PR's I think you'll agree that SMI has failed to fulfill their promises time and time again. The good news is that the China clinical study with 400 participants was apparently completed and was successful; that will bolster GTHP's amended PMA when they submit.

I have no doubt that the US clinical trial will be successful and that GTHP will submit the amended PMA. After that, it's hard to say how long the FDA will take to review the PMA, but it's an amended PMA, not a brand new submission. I also never assume any FDA submission is a slam dunk, but in my opinion, this is as close to a slam dunk as it gets.

I'm not sure why our resident basher is trying so hard to raise FUD. My only guess is that he held after that 2015 FDA rejection, which is something I've learned not to do -- yes I lost money in 2015 but I accept the risk of FDA plays, so I sold my entire position the day after that PR, took my loss, and moved on, watching and waiting. If our basher held, the R/S's in 2016 reduced his position to ashes, which I guess would make anyone bitter.

When that 2019 R/S held its resulting 15 cents, I started getting back in. It's not common for a pennystock developmental biotech hold its price after a R/S. It's SUPER uncommon. Our resident basher thinks the PPS should be at $5 but I'm surprised it didn't fall to a penny after that 3rd R/S.

So here we are, close to the milestone of completing that clinical trial and submitting the PMA. It would be nice if SMI mails a check because GTHP has to be out of cash by now, so I expect some bridge financing if SMI doesn't pony up. $500,000 from SMI in March would be a godsend, IMO, but again, I'll believe it when the check clears.

Also of note: it's important to know that the giul lawsuit against shenghuo does not name GTHP as a defendant. The lawsuit started in 2019 and originally it did name GTHP, but the company has since been removed from the lawsuit.

Cheers.
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