Guided Therapeutics Inc (GTHP)

[GetSeriousOK]

R/S not effective yet - FINRA has to declare the effective date.

And the ticker will likely change to GTHPD

The S-1 and S-1/A are both preliminary.

Looks like the R/S will happen first, then the offering.

And still no word about when the clinical trials will start in the USA. The clinicaltrials.gov page still shows the Primary Completion Date as Sept. 30, 2022, but that likely will get pushed back.

https://clinicaltrials.gov/ct2/show/results/NCT04915495?view=results

[myjo]

After 1:20 RS the float will be below 1ML. For NASDAQ listing the float should be minimum 1.5ML. How are they going to achieve that?

[GetSeriousOK]

the lenders who saved this company from death spiral financing want it uplisted to the NASDAQ.

[myjo]

Outstanding is just 13.6 ML, so what are they going to get by doing RS 1:20 now? Why would they be doing 1:20 RS other than just for screwing stockholders?

If they issue more stock, if that newly issued stock not going to come into float, then where’s it going to go? Is that newly issued stock going to come to market for sell immediately?

[myjo]

Very bad!

[GetSeriousOK]

20:1 reverse split will likely be effective Monday.

https://www.otcmarkets.com/filing/html?id=15468124&guid=BzvwkpbfgjjNB3h

https://www.otcmarkets.com/filing/html?id=15468124&guid=BzvwkpbfgjjNB3h#GTHP_EX31_HTM

[splintered sunlight]

Why all the 1 share prints?

[GetSeriousOK]

When they do the reverse split in December, this is going to get weird. The float is going to be ridiculously low. Couldn't even fill a Christmas Stocking with that float.

The float as of 6/30/2021 was only 3.8 million shares. Assume they do a 1:20 R/S -- divide 3.8 million by 20... there's going to be less than 200,000 shares in the float.

Granted, they will issue more stock as described in the S-1. But that new stock won't go into the float.

At first I thought "no way they will do that proposed R/S, that would be folly," but then I realized that they ARE actually going to do that R/S, so I sold. I'm on the sidelines now. This could go either direction and my risk tolerance has dropped a lot lately. I plan to get back in when I see the FDA submission on the horizon but that's a year away now.

I'm still very impressed with this CEO and what he's done. GLTA who are going to hold through the R/S.

[GetSeriousOK]

A/S has officially been reduced to 500,000,000 as per the "Charter Proposal."

the R/S is probably coming next. The S-1 says it will be on or before Dec. 31st 2021.

[GetSeriousOK]

10-Q has an update on the clinical trials.

As of November 10, 2021, clinical trial agreements have been drafted and agreed upon, the budget at one institution has been agreed upon and is under negotiation at the other institution. The LuViva devices have been prepared and have passed bench testing in order to begin the study. All requested materials have been submitted for review by the respective hospital institutional review boards (IRBs). Once the IRB’s have approved the study, enrollment may begin, which is expected prior to the end of this year and last approximately eight to nine months; however, there can be no assurance that the study will begin in 2021 or that it will be completed by the end of 2022.

In China, the study protocol and budgets have been agreed upon at two clinical centers and the study has begun at one center, with two more to be added this year. This study will enroll approximately 320 women and is expected to be completed in the first half of 2022, although there can be no assurance that the study will be completed within this time frame.

[myjo]

Exactly. Stupid is what stupid does.

When the matter is under investigation & judicial review then sane people don’t comment on it.

So much so for so-called 20 years of following biotech companies listed on OTC
&
So much so for so-called “educated & informed”. LOL!

[GetSeriousOK]

I couldn't agree more. Stupid is as stupid does.

Keep us informed about your adventures with the SEC enforcement attorneys.

LOL

[myjo]

Stupid is what stupid does!

As per US Supreme Court guidelines & the accurate interpretation of USFDA laws & SEC Rules & Regulations about clinical trials, what matters is the “intent” of the responsible party (in this case it’s GTHP & it’s board). Their “intent” is to start US clinical trials “asap”. At least that’s what they have been claiming in their PRs. Their “intent” is NOT to “keep on preparing indefinitely” for starting US clinical trials. So on their clinicaltrials.gov entry they “must” have mentioned “Contacts & Locations” of all those sites that they are targeting for starting US clinical trials. Since they haven’t mentioned all this information this entry has absolutely no meaning from the perspectives of those who are truly “educated & informed” & those who know laws, rules & regulations versus those who “claim” to be so-called educated.
Not mentioning “Contacts & Locations” information “inadvertently” is not a civil or criminal violation. However when stockholders repeatedly warned/informed you about this potential “violation” & then “deliberately” ignoring those warnings so as to “hide” relevant information from stockholders is a civil as well as criminal offence.

Next week hopefully FDA SEC & Department of Medical Devices of FDA will review all this & hopefully take some enforcement action if they deem necessary.

[GetSeriousOK]

Oh please. EACH of those biotechs hides behind Safe Harbor statements.

They all do.

AEMD, good god, I've followed that company for 20 years. What a POS it has become. They promised to get get the Hemopurifier to market YEARS ago, using Safe Harbor statements, and I now doubt they will EVER get that thing to market. AEMD used to be run by a competent CEO named James Joyce but he's long gone. AEMD has become a zombie and hides behind Safe Harbor statements all the time.

Compare GTHP and AEMD on a 1-year and 2-year stock chart: GTHP has outperformed AEMD on both. And let's see which gets to market first: AEMD's Hemopurifier or GTHP's LuViva Scan.

LOL what a bunch of bullshit.

[GetSeriousOK]

The entry at clinicaltrials.gov doesn't mean anything to the uneducated and ignorant. That does NOT describe the SEC's enforcement attorneys. It means something to them, and to me.

The USFDA law & SEC’s Rules & Regulations says that any biotech company engaged in clinical studies / trials must disclose their sites’ information , but Guided is not engaged in a clinical study yet. Right?

LOL

[myjo]

Every publicly traded biotech hides behind Safe Harbor statements.

It would be better before making such completely BS statements, if you do due diligence. Many biotech companies like NAOV, PALI, AGTC, KMPH, AHPI, AEMD etc. they are run by performing & high capability management. They don’t hide behind safe harbour statements. These companies announced when exactly they will start their clinical trials or earnings revenue & they did what they said they will do. That’s why Wall Street rewarded them with more than 100% gains in their stock price.

Only those companies hide behind safe harbour statements who have anything or something to hide. Those management take shelter under safe harbour statements who are non-performing & no-capability.

I don’t want to argue anymore. I can’t change people’s believes that angels are real & pigs do fly!

[myjo]

This entry at clinicaltrials.gov has no meaning at all.

If you look closely they didn’t mention “Contacts & Locations” & Recruitment Status : Not yet recruiting

Until they start Recruting and update this with Contacts & Locations, this entry doesn’t mean anything.

The USFDA law & SEC’s Rules & Regulations says that any biotech company engaged in clinical studies / trials must disclose their sites’ information (to stockholders). It’s up to SEC’s enforcement attorneys to interpret the law accurately / correctly & then determine if GTHP violated the laws or not & then take necessary enforcement action.

[GetSeriousOK]

Every publicly traded biotech hides behind Safe Harbor statements.

"Absolutely nothing has materialised yet?" LOL, be sure to tell that to the SEC enforcement attorneys. But don't let them find the Protocol, the S-1, or this web page:

https://clinicaltrials.gov/ct2/show/study/NCT04915495

[myjo]

As per USFDA’s laws about clinical trials‘ information disclosure and SEC’s Rules and Regulations about clinical trials’ information disclosure : FDAAA801 42 CFR Part 11 Section 223, 208(b)(1), 107(a)(2), section 552 of Title 5 United States Code And as per SEC Rule SEC CFR 45, 43 Part 11; GTHP & Gene “should” have disclosed medical sites’ information and at what stage each site is; to stockholders. Which they haven’t done it yet, in spite of repeatedly asking to disclose that information to stockholders. Hopefully SEC’s enforcement attorneys will look into this as a possible violation of laws.
Plus there are many more which I don’t want to discuss here.

[myjo]

They always hide behind safe harbour statements. They were preparing right from start of this year. First they were preparing to start trials by 2Q end 2021. Then they were preparing to start trials by September & October. It’s almost October 2021 end & they are still preparing. Absolutely nothing has materialised yet. Smart Wall Street knows what it means.
Yes possibly SEC’s enforcement attorneys laugh at me but there’s also a possibility that SEC enforcement attorneys may start scrutinising GTHP & it’s board more closely at least this will get GTHP & it’s board on their radar.

[GetSeriousOK]

You'll be talking to "enforcement attorneys" next week? That's funny!

It's a PRELIMINARY S-1 -- "The information in this preliminary prospectus is not complete and may be changed." An SEC enforcement attorney would laugh in your face. But by all means, you go, girl.

And even if it WERE a final S-1, "Preparing to start the study" is a Safe Harbor statement. They didn't say "we will start the study in September or October." They said they were PREPARING to start. You'd have to prove they were NOT "preparing to start the study."

[myjo]

Yes, I read that. On page 19 they say

Currently, we have agreed with the U.S. FDA on the clinical trial protocol and are preparing to start the study of approximately 400 women in either September or October 2021.

Report was filed on October 07th 2021 & they say study will start in September or October 2021. Lol!

Still 1 week remaining for October 2021 end. Let’s see what happens.

I’ll be talking to SEC’s enforcement attorneys next week.

[GetSeriousOK]

Anyone else read that S-1?

Interesting. Especially reading BETWEEN the lines.

[GetSeriousOK]

I might have to start taking SMI seriously.

https://www.otcmarkets.com/stock/GTHP/news/Guided-Therapeutics-Ships-LuViva-Devices-to-China-for-Start-of-Clinical-Trial-Receives-Additional-100000-Payment?id=323793

even if it's baloney... $100,000 is $100,000

[GetSeriousOK]

LOL, first it was "they have no plans to run clinicals."

Then when it was obvious they planned to run clinicals, it was "they'll never get the money."

Then when they got the money, it was "they will never start clinicals." Which is laughable since they spent so much time and effort writing the protocol and getting it reviewed by the FDA.

When clinicals start, it will be "they'll never finish the clinicals."

When they finish the clinicals, it will bhe "they'll never submit anything to the FDA."

And when they submit the PMA, it will be "the FDA will reject it."

So futile, so silly, so unproductive, and so pointless.

[myjo]

The critique is based on evidence.

Clinical trials were supposed to start by June end. September end is gone & still nothing.

I suggest send email to Gene and ask him when US clinical trials starting?
Or
Ask him, if clinical trials starting at all?

If at all he answers any of those questions, be prepared to have your “belief” shattered!

[GetSeriousOK]

LOL, Nice to see the consistency, anyway.

[myjo]

You said it right

I need evidence to prove a belief?

Nice to know that there are still some who believe that angels are real.

[GetSeriousOK]

When they start the clinical trials, what's the bash going to be THEN?

Will it be "yes they started but they will never finish?"

It's important to start planning the BS ahead of time in order to be ready.

This study is a matched pair design, single-arm study with the following two treatments: current standard of care (SOC) and the LuViva study device. After undergoing the LuViva test, all study subjects will first undergo the SOC (i.e., nominal) colposcopy, with the colposcopist noting on the case report form (CRF), locations of lesions with colposcopy impression of CIN1+. Then the colposcopist will employ enhanced colposcopy measures that include the use on Lugol's solution and green/blue filters. The colposcopist will note on the CRF any additional lesions that became evident as a result of these enhanced measures, regardless of colposcopic impression. Biopsies of these lesions will be taken. Biopsies identified using SOC practices will be placed in vials labeled "SOC Biopsy Samples". Biopsies identified using enhanced practices will be placed in vials labeled "Enhanced Biopsy Samples". The colposcopist will then take a biopsy from any quadrant at the squamocolumnar junction (SCJ) in which a lesion was not observed. These biopsies will be placed in a third vial labeled "Random Biopsy Samples". Additionally, in the instances when the SCJ is not completely visible, an endocervical curettage (ECC) will be taken and placed in a vial labeled "ECC Biopsy Samples". The study is a matched pair design because all subjects are tested with the LuViva device and all will undergo both the nominal (minimal) colposcopy and biopsy treatment pursuant to ASCCP Guidelines as well as enhanced colposcopy and biopsy. By analyzing all biopsy specimens from SOC procedures and enhanced procedures, it can be determined 1) Whether enhanced procedures can be justified when the LuViva test indicates High-risk by the increase in detection of CIN2+ and 2) That when LuViva indicates Low-risk, that enhanced procedures (in the absence of a LuViva High-risk result) are not the reason for increased detection of CIN2+. Subjects will be enrolled during their normally scheduled colposcopy visit and will be recruited from the pool of patients that are referred to colposcopy based on the ASCCP Guidelines published in April 2020. The total number of enrolled female subjects pooled across all clinical sites combined will not exceed 500 in order to target an evaluable cohort of approximately 400 women.

[GetSeriousOK]

I need evidence to prove a belief?

Fine. My evidence is:

* the CEO has done a miraculous job of pulling this company out of the black hole of toxic financing. STARTING clinical trials is easy, compared to that.

* as of the last financial statement, they had the $1 million and they hadn't spent it on anything else yet.

* they created a page on clinicaltrials.gov

* the entities currently funding this company believe Gene, and they have access to more information than I.

Now lets' hear YOUR "evidence."

[myjo]

Did you hear this from Gene?

Do you have any evidence to prove your belief that they will start US clinical trials?

Do you even know whether they are currently working on starting US clinical trials?

Do you know what they are currently working on?

Have you ever visited their office in Peachtree, GA to ensure that GTHP is a real company not a shell formed to cheat & deceive stockholders?

[GetSeriousOK]

I believe they will start clinical trials in US.

Makes no sense to believe otherwise.

Is it happening as fast as shareholders would like? No, it is not. Boo hoo for shareholders. It's a pinksheet stock. Nobody is pretending it's a blue chipper.

Well, ALMOST nobody. :)

[myjo]

June end gone! July end also gone! August end also gone!

Does anyone still believe in GTHP management such that they will start clinical trials in US?

[myjo]

Does anyone know what medical facilities they are targeting for potential clinical trials’ sites? Does any one know those details?

[GetSeriousOK]

Rats are rats.

[myjo]

Rats are frustrated about why clinical trials in US haven’t started yet?’ They are asking why & where’s the hold up in starting US clinical trials?!
Rats are bearish on China. Let’s see who delivers!

[GetSeriousOK]

When’s the ship is sinking rats are the first ones to abandon it!!

At what point did you realize that you are a rat?

Just curious. Mildly. Actually, don't care at all.

I'm bullish on GTHP, bearish on SMI. This PR just reinforces my opinion. It's important to speak the truth and keep an open mind, a MB tenet that is obviously beyond some participants.

[GetSeriousOK]

Tedious.

[myjo]

Vow! “Disappointing PR”?! Seriously?! Really?!
Where’s all that optimism?! & moreover where are those trades to “show” that money is being put where mouth is?!
No wonder when push-comes-to-shove & when the time comes to “show” that braves really put their money where their mouth is, cowardice always run for the hills!
When’s the ship is sinking rats are the first ones to abandon it!!

[GetSeriousOK]

Disappointing press release.

No mention of US clinicals. What's causing the delay?

No explanation about why SMI failed to pay the promised $500,000 last quarter.

And no explanation of what "regulatory compliance review" in China entails or even means. The bottom line is: Chinese clinicals have not started yet.

"SMI estimates that the clinical study will be completed during the second quarter of 2022 with full approval to sell in China expected by the end of 2022?" News flash: Even if they complete clinicals in Q2 2022, there's no way the CFDA will grant full approval by the end of that year. It simply doesn't happen that fast.

SMI continues to spew BS, which is no surprise. I don't blame Gene for repeating the BS that SMI dishes up. And they did pay $133,000 for "parts and advice" which is better than nothing.

What "parts," though?

[shanak10]

https://www.otcmarkets.com/stock/GTHP/news/story?e&id=1976922

[GetSeriousOK]

Disagree - I'm quite certain they can get FDA approval without any sales. Most developmental biotechs have to get FDA approval BEFORE they can sell anything.

And they're not "headed to the pinks," IMO. They just clawed their way OUT of the pinks last year -- they are not headed back anytime soon.

I do agree with "Another reverse split? Why bother?" because that wouldn't be necessary to remain on the OTCQB, so why bother indeed?

[Zeppo]

Well.....one has to ask oneself some obvious questions. Why no sales to existing customers? That fact alone will thwart any effort to start a human clinical trial. Where will the much needed global stats emerge to offer efficacy results to support that clinical trial? The company doesn't have a lot of options. Merck continues to offer its vaccine for this indication. Another reverse split? Why bother? This thing is headed to the pinks and then OUT without the prospect for approval in the developed world.

[myjo]

Smart Wall Street thinks that you are the most incompetent, inept, lazy, zero-performance and no-capability CEO a public limited company could ever have.

It’s been 1+ month since 2Q 2021 end and still no US clinical trials started yet.

It’s been 5+ months since you raised 1.1ML$ via toxic financing and no US clinical trials have started yet.

You only say that selling LuViva to those countries where you already have regulatory approval is your priority, but those are just words. No action. You are incapable of any action.

If you have any basic human values still left in you (smart Wall Street seriously doubts you have any human values!) like honesty, integrity and truthfulness then this is the right time to inform stockholders what’s the “true” status of US clinical trials start.

GTHP stock is down today again(no surprise here). Under your helm this stock will never ever see a green!

[GetSeriousOK]

Tedious.

[myjo]

If they raised 1.1ML$ for starting clinical trials in US, then did clinical trials start by 2Q2021 end? Did they start right now?

If smart Wall Street is BS then stock would not have been down.

Those who think management is doing great job & it’s a good bet, feel free to buy stock. Plenty available at 0.50$. How much you are buying. It’s time to put your money where your mouth is!

[GetSeriousOK]

They raised $1.1M but it was NOT from toxic financing and it is NOT for manufacturing the device. It's for clinical trials.

So:

1. The Clinical trial process started last year when they finally resumed communication with the FDA regarding the protocol. The process continues: the most recent development is the creation of a page on clinicaltrials.gov. Has recruiting started? Apparently not yet.

2. According to the last 10-Q they are not selling LuViva to anyone. This month we'll see another 10-Q, but sales will likely still be non-existent.

Let's discuss the definition of "Smart Wall Street." What does that mean? Who is "Smart Wall Street?" Is it just bullshit? Of course it is.

[myjo]

Let’s focus on

1) If US clinical trials starting?
2) If they are selling LuViva to those countries where they already have regulatory approval?

Up till now the “lame” excuse was, we don’t have funds for manufacturing LuViva so we can’t make any LuViva & sell it to those countries where we have regulatory approval. That “lame” excuse no longer holds true, because they raised 1.1ML$ via toxic financing 3 months ago. Now in spite of having 1.1ML$ for 3 months, why single LuViva was not manufactured or sold? Answer to that question will also answer why Wall Street thinks “they stole 1.1ML$”.!

[GetSeriousOK]

Who, exactly, is "Smart Wall Street?"

Name one entity that is part of this mythical fraternity known as "Smart Wall Street."

GTHP is a penny stock. Institutions and Funds don't buy penny stocks.

GTHP is an OTCBB stock. Institutions and Funds don't buy OTCBB stocks.

The difference between Smart OTCBB penny-stock investors and Stupid OTCBB penny-stock investors is: the smart ones know a good bet when it comes along. GTHP was a bad bet between 2014 and 2019. GTHP became a good bet in 2019.

Dwelling on the old pre-2019 GTHP is not something a Smart OTCBB investor would do.

[GetSeriousOK]

Yes, they have regulatory approval to sell in Europe.

https://www.businesswire.com/news/home/20120718005191/en/Guided-Therapeutics-Notified-of-CE-Mark-Approval-for-LuViva%C2%AE-Advanced-Cervical-Scan

Yes, they have sold the device in Europe and the Mideast, but they could not deliver because they had no money for manufacturing.

Everything hinges on US FDA approval. Will they start the trials? I say yes. Will they complete the trials? I say yes. Will they get FDA approval? I say yes.

Maybe I'm wrong but I like the odds here. I do NOT like the odds of sitting on the sidelines, constantly complaining and griping -- there's no money to be made in THAT strategy.