Samumed Sm04554 Results Normalized To Baseline

[Ralph Wiggum]

Well triple hair still due to release their TH16 by May apparently so let’s see

I started hearing about TH16 and it sounded so promising, but I just Googled the creator (Dr. Satish Asotra) and he's a hippy dippy goon who promotes unscientific "alternative" practices, so let's hope this product is legit.

 

[Ralph Wiggum]

TH16 isn't going to do much, its just topical resveratrol and melatonin. You can but it now and make it at a fraction of the cost they'd charge.

Thanks. They claim that it outperformed 5% minoxidil...?

 

[Ralph Wiggum]

Did they show data, images or even say in what model it outperformed minoxidil? If not I'd take it for what it is, an unsubstantiated claim.

Right now it just says: "In our Phase II clinical trials, TH-16 proved more effective than Minoxidil 5%." I'll try to contact them for more info.

 

[Janko]

Lol they didn't cancel their entire pipeline, they cleaned up their pipeline section. And I see it as a good thing, focussing on the things they believe in.

Btw, for the idiots who're crying about "where the results at?!", it's only march. The phase III study only recently ended on 31 december. (https://clinicaltrials.gov/ct2/show/study/NCT03742518)

And remember we're still in covid times. Hell, we're lucky the trial is completed and didn't have any delays.

So to conclude, there's absolutely nothing pointing to things "not going well" so far. Let's hope we'll see the results in the first half of this year.

That is actually the issue. The trial finished without any delays on 12th of January. That means, they collected all the photos already. Some of the users ended the trial at the late autumn. How long do you think, that counting of 1cm2 for one team would take? Even if one patient would take 2 hours to measure from photos and there would be only 5 members of the team it wouldnt take that extra long time. 675 patients would take in that case 34 working days, so in two months you should have numbers and after that it is just one day for average data analyst to make the results. Some companies are able to release their trial results 3 months after completition, but that trial was for cirrhosis of the liver etc. That is much harder to collect data. Pharma company my father works in realeased their trial for asthma drug only 2 month after it ended. And that was collecting of blood results etc.

I do not agree completely with pegasus2 opinion on Samumed since I like their approach, but in our case every product is a scam until proven otherwise. Since they should already have at least idea if it works or not.
Another thing, why they havent started the talks with FDA? There is no record about that in FDA. Only the formal sh*t you need to go through before they will be judging the product and start approval process takes ages. Wouldnt you want to move forward through this with working product? And they havent submitted even the phase 2 talks yet.

I trully hope, that I will be proven wrong, but if they won't release any results before the end of April, it will be another failed attempt.

 

[pegasus2]

The pipeline was reduced because they don't have the money to work on more drugs. What happened to all the money they raised? Other companies are able to develop a half dozen drugs on far less money. Everyone knows that lorecivivint failed. The only reason for extending the trial is to dupe more investors. SM04554 failed too or they wouldn't have needed to purge their pipeline, the money would've been rolling in. Their alzheimers drug finished preclinicals four years ago and has gone nowhere since then yet I'm supposed to believe it has potential. The only thing with any potential is their pancreatic cancer drug, and I don't think that's going to work either. Goodnight Samumed. Last one out turn out the lights.

 

[clams]

I work in clinical research at a pharmaceutical company. IMO we should get a press release any week now if the data is positive, they have had plenty of time to get the data ready at this point.

 

[trialAcc]

That is actually the issue. The trial finished without any delays on 12th of January. That means, they collected all the photos already. Some of the users ended the trial at the late autumn. How long do you think, that counting of 1cm2 for one team would take? Even if one patient would take 2 hours to measure from photos and there would be only 5 members of the team it wouldnt take that extra long time. 675 patients would take in that case 34 working days, so in two months you should have numbers and after that it is just one day for average data analyst to make the results. Some companies are able to release their trial results 3 months after completition, but that trial was for cirrhosis of the liver etc. That is much harder to collect data. Pharma company my father works in realeased their trial for asthma drug only 2 month after it ended. And that was collecting of blood results etc.

I do not agree completely with pegasus2 opinion on Samumed since I like their approach, but in our case every product is a scam until proven otherwise. Since they should already have at least idea if it works or not.
Another thing, why they havent started the talks with FDA? There is no record about that in FDA. Only the formal sh*t you need to go through before they will be judging the product and start approval process takes ages. Wouldnt you want to move forward through this with working product? And they havent submitted even the phase 2 talks yet.

I trully hope, that I will be proven wrong, but if they won't release any results before the end of April, it will be another failed attempt.

I think you need to find a dictionary and look up the definition of scam. A product that fails to show efficacy in phase 3 clinical trials is not a scam, it's just a failed new product.

Also, as far as I'm aware, you don't engage the FDA for NDA without having pivotal study data, which is the data from this trial. Companies have very different timelines when it comes to these things, so your anecdotal experience from some asthma drug that was probably tested on 30 people doesn't mean anything in regards to this trial.

 

[trialAcc]

I work in clinical research at a pharmaceutical company. IMO we should get a press release any week now if the data is positive, they have had plenty of time to get the data ready at this point.

Yeah agreed, certainly some sort of press release with some very top line data should be imminent.

 

[trialAcc]

The pipeline was reduced because they don't have the money to work on more drugs. What happened to all the money they raised? Other companies are able to develop a half dozen drugs on far less money. Everyone knows that lorecivivint failed. The only reason for extending the trial is to dupe more investors. SM04554 failed too or they wouldn't have needed to purge their pipeline, the money would've been rolling in. Their alzheimers drug finished preclinicals four years ago and has gone nowhere since then yet I'm supposed to believe it has potential. The only thing with any potential is their pancreatic cancer drug, and I don't think that's going to work either. Goodnight Samumed. Last one out turn out the lights.

This doesn't even make sense. Why would money be rolling in because SM04554 had positive data? They have no sales of the drug until a commercial release and it's unlikely they would ever go out and raise funds to just submit a NDA.

A company makes changes to it's website graphics and the internet thinks it's enough to infer that the company is broke when they are literally recruiting for a 500 person study and still hiring like crazy.

 

[pegasus2]

This doesn't even make sense. Why would money be rolling in because SM04554 had positive data? They have no sales of the drug until a commercial release and it's unlikely they would ever go out and raise funds to just submit a NDA.

A company makes changes to it's website graphics and the internet thinks it's enough to infer that the company is broke.

Now you're being disingenuous. You know it's more than just a change to website graphics. They removed all but four drugs from their pipeline.

Yes, if they had positive data from a phase III trial they would be able to raise another 30 million almost overnight to keep their other drugs proceeding.

This is a scam not because it failed but because in all likelihood they knew it would fail before they took their investors for millions of dollars. They aren't stupid people and they have a background in this stuff. I personally do not believe that they ever really believed in this treatment. But somehow they burned through half a billion in a few years. Meanwhile Surrozen only needed 50 million to fund all this:

The difference is one is using the money to fund the business whereas the other is probably using the money to fund their lifestyle. Mind you I have no evidence of this, it's just a suspicion.

 

[trialAcc]

Now you're being disingenuous. You know it's more than just a change to website graphics. They removed all but four drugs from their pipeline.

Yes, if they had positive data from a phase III trial they would be able to raise another 30 million almost overnight to keep their other drugs proceeding.

This is a scam not because it failed but because in all likelihood they knew it would fail before they took their investors for millions of dollars. They aren't stupid people and they have a background in this stuff. I personally do not believe that they ever really believed in this treatment.

I'm not being disingenuous at all, and again, you have 0 evidence into anything regarding them having knowledge into whether or not their drugs would certainly fail the clinical trial process. It would be far less damaging for them to take a step backwards and work on better delivery methods or compositions then to pour hundreds of millions into phase 3 trials for products they know will fail and will certainly be the death blow to the company when realized.

You've just built up your opinion of them because people on a forum didn't get crazy results using grey market sourced materials. Meanwhile, phase 2/3 for both SM0445 and lorecivivint showed clinical results worth of the continued studies.

 

[pegasus2]

I'm not being disingenuous at all, and again, you have 0 evidence into anything regarding them having knowledge into whether or not their drugs would certainly fail the clinical trial process. It would be far less damaging for them to take a step backwards and work on better delivery methods or compositions then to pour hundreds of millions into phase 3 trials for products they know will fail and will certainly be the death blow to the company when realized.

You've just built up your opinion of them because people on a forum didn't get crazy results using grey market sourced materials. Meanwhile, phase 2/3 for both SM0445 and lorecivivint showed clinical results worth of the continued studies.

I just said I don't have any evidence that they are fraudulent. I was explicit about that because I want to be fair, so I'm not sure how you think you got me with that point. Neither trial met clinical end points for efficacy, but keep believing that. I didn't believe in Samumed before anyone on the forum had even tried it. I personally never even bothered with it even though it's cheaper than most of the stuff I use. I never believed in it because of their secrecy regarding the method of modulation for the Wnt pathway, the other shadiness that's been discussed in this thread, and my understanding of the Wnt pathway and A.G.A. The only drug they've been upfront about is the cancer drug inhibiting clk, which is the only one I think has a shot at working. If SM is simply upregulating clk then it has no shot. There are too many negative feedback mechanisms downstream of clk in A.G.A. If it phosphorylates GSK3b then it will work but not as well as minoxidil.

Edit: lol @ hundreds of millions of dollars for a phase III trial. 40k per patient is the average cost for a phase III, and for some reason theirs is being conducted in-house so they are saving money. https://www.sofpromed.com/how-much-does-a-clinical-trial-cost

 

[trialAcc]

I usually appreciate trialacc very much, but when a company removes almost all drugs from the pipeline, that says a lot

What does it actually say about the results of the phase 3 trial of SM0445?

That's my point, it says nothing.

 

[trialAcc]

I just said I don't have any evidence that they are fraudulent. I was explicit about that because I want to be fair, so I'm not sure how you think you got me with that point. Neither trial met clinical end points for efficacy, but keep believing that. I didn't believe in Samumed before anyone on the forum had even tried it. I personally never even bothered with it even though it's cheaper than most of the stuff I use. I never believed in it because of their secrecy regarding the method of modulation for the Wnt pathway, the other shadiness that's been discussed in this thread, and my understanding of the Wnt pathway and A.G.A. The only drug they've been upfront about is the cancer drug inhibiting clk, which is the only one I think has a shot at working. If SM is simply upregulating clk then it has no shot. There are too many negative feedback mechanisms downstream of clk in A.G.A. If it phosphorylates GSK3b then it will work but not as well as minoxidil.

Edit: lol @ hundreds of millions of dollars for a phase III trial. 40k per patient is the average cost for a phase III, and for some reason theirs is being conducted in-house so they are saving money. https://www.sofpromed.com/how-much-does-a-clinical-trial-cost

Yes but they've done three phase 3 trials for lorecivivint and one 650 person trial for SM0445. Add those all up and you're getting into the 9 figure mark by your own metrics.

 

[pegasus2]

Yes but they've done three phase 3 trials for lorecivivint and one 650 person trial for SM0445. Add those all up and you're getting into the 9 figure mark by your own metrics.

They aren't spending anywhere near 40k per patient because they are doing them in-house, which in itself is shady.

 

[trialAcc]

They aren't spending anywhere near 40k per patient because they are doing them in-house, which in itself is shady.

I'll take your word for it. Like I've said the entire time, I'll be waiting for the data and will be happy to admit I was wrong if it's a dud. Just hoping for something I can add to my stack without worrying about sourcing things myself.

 

[Gegen]

 

[trialAcc]

indirectly it could allow some conclusions. The results could have been disappointing, so that one is no longer so convinced of the long-term effectiveness and would like to concentrate on products that are already running. Or investors are no longer so enthusiastic. We do not know it. The fact is that the CEO advertised his company very aggressively in interviews. He specifically said that his products would cure many diseases. Even alopecia. Perhaps investors really believed that and are now unconvinced of 35 percent regrowth

There's no sense in wild speculation, that's my whole point. Like you said, we do not know, so why bother guessing? If the results either don't come or are announced and are poor then we can probably assume that they had to make cuts to the broad pipeline because one of their major pipeline items failed trials and wont be generating revenue anytime soon.

 

[Valkyyr]

Just to let you know - congress on which purportedly the results were to be released already took place:

11-14th of march

8. Dermatology and Cosmetology Congress With International Participants

And nothing has been released. So not in march folks.

 

[MrV88]

3...2...1.. where are my Samumed is scam boys?