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sunspotter your manipulation intent becomes clearer with every post you make. You are saying that these highly respected authorities in the field of hepatology are blindly signing off on a conference presentation, putting their names as authors but not thinking about the content.
OMG you are quite something. Again, look at the bios of the authors and realize that if you continue to assert this you are actually putting yourself in legal jeopardy for defamation. These people who spend their lives studying liver disease and treatments will be interested in defending their reputation against a prolific stock board keyboard warrior.
Title: Belapectin at 2 mg/kg/LBW Reduces Varices Development in MASH Cirrhosis with Portal Hypertension: Results from the NAVIGATE Trial
Abstract Number: LB-006/ LB25183
Session: Poster, Complication of Cirrhosis, Portal Hypertension
Authors: Naim Alkhouri, Raj Vuppalanchi, Mazen Noureddin, Mitchell Shiffman, Eric J. Lawitz, Edward Mena, Nadege Gunn, Khurram Jamil, Stephen A. Harrison, Naga Chalasani
Date, time & location: Saturday, May 10, 2024: 1:00 PM - 2:30 PM, CET RAI Amsterdam
"The authors who are well respected authorities in the field are taking everything into consideration and don't just skim headline sound-bites like what you're doing."
"Alex M. writes, "A colleague mentioned he had been persuaded to buy Pro-Pharmaceuticals (now renamed as GALT -my note) a few years back, and after years of languishing in losses, he's wondering whether it's actually a real company with a real drug candidate, Davanat, or whether it's an out-and-out scam or somewhere in between... Do you have a view on this company? I'm a huge admirer of your column, and have to admire anyone who flushes CEOs of companies like Generex (GNBT) and Cell Therapeutics (CTIC) out of the woodwork in the way you have. I suspect that makes you eminently qualified to comment on Pro-Pharmaceuticals."
I called the public relations people working with Pro-Pharma on Wednesday asking for slides and/or published articles so that I could review the phase II data on Davanat in colon cancer, the drug's lead indication.
Pro-Pharma's spokeswoman explained to me the company hasn't presented or published any of the Davanat data (from a study conducted in 2004-2006) because the FDA places "serious restrictions" on publishing clinical data without the agency's approval.
"Since Pro-Pharmaceuticals is in the design stage of phase III based on its phase II study, the company has not applied to the FDA regarding publishing the
phase II clinical data," the company spokeswoman told me in an email, after she consulted with Pro-Pharma's chief scientist AnatoleKlyosov.
I'm not identifying the spokeswoman because she's nice and is just doing her job. No need to embarrass her any further.
Naturally, the biotech B.S. detector chip implanted in my brain went into red alert mode after hearing that cockamamie excuse for not sharing old phase II data. The story doesn't get any better after reading what little Pro-Pharma has said publicly about Davanat.
Pro-Pharma claims to have run a phase II study enrolling 25 patients with advanced colon cancer treated with Davanat and the chemo drug 5-FU in which the median overall survival was 6.7 months, or 46% higher than the 4.6-month median overall survival for patients treated with best standard of care.
Except that survival advantage is totally made up because the study treated all patients with Davanat and 5-FU, with no control arm to perform any credible analysis of a survival benefit. Pro-Pharma acknowledges this in the fine print of its corporate slides, stating that the 4.6-month median overall survival for patients treated with best standard of care comes from a "recent publication" i.e. someone else's clinical study.
Davanat is supposed to increase the amount of chemotherapy that can be administered to a patient while also decreasing the side effects. After looking at the sparse clinical data available on Davanat, my confidence level in the authenticity of these claims is rather low.
Pro-Pharma seems to operate on a shoestring budget, which has forced the halt to several other studies of Davanat. It's not entirely clear if any of the Davanat studies were ever completely finished per design; Pro-Pharma says it stopped the phase II colon cancer study, for example, because "we achieved our objective."
Um, but usually, companies complete patient enrollment and treatment before conducting an analysis and concluding that a study's objectives were met. For some reason, Pro-Pharma operates clinical trials backwards. Maybe this is why it's the only company in all of biotech that needs FDA permission to present or publish phase II data?
On Wednesday, Pro-Pharma said it was moving ahead with plans for a commercial launch of Davanat in Colombia. That's Colombia, the country in South America. Apparently, Colombia President Alvaro Uribe is really excited about bringing Davanat to all Colombians suffering from colon cancer.
I'll stop now. Alex, I hope you have your answer.""
The authors already took all of that into consideration. In fact there are plenty of drugs that had to refine their target population after phase 2, which includes the blockbuster immunotherapy drug Keytruda (which did not do well in p2 studies until the subgroup was defined). An example that is more specific to liver disease is CymaBay, which refined their targeted disease/subpopulation approach after p2 and then later was acquired by GILD for $4.3B.
You're really grasping for straws after the positive news, sunspotter. The authors who are well respected authorities in the field are taking everything into consideration and don't just skim headline sound-bites like what you're doing. I'll listen to experts in the hepatology field, not some anonymous chat board poster with zero hepatology background who is feverishly posting on a stock board 24/7.
Title: Belapectin at 2 mg/kg/LBW Reduces Varices Development in MASH Cirrhosis with Portal Hypertension: Results from the NAVIGATE Trial
Abstract Number: LB-006/ LB25183
Session: Poster, Complication of Cirrhosis, Portal Hypertension
Authors: Naim Alkhouri, Raj Vuppalanchi, Mazen Noureddin, Mitchell Shiffman, Eric J. Lawitz, Edward Mena, Nadege Gunn, Khurram Jamil, Stephen A. Harrison, Naga Chalasani
Date, time & location: Saturday, May 10, 2024: 1:00 PM - 2:30 PM, CET RAI Amsterdam
Sigh.
Some more facts, this time from the NEJM, and facts are always more convincing than ad hominem attacks, which just reveal the paucity of the attacker's position, as well as their lack of morality:
"Do Subgroup Findings Elicit Positive Signals?
Although it is appropriate to consider subgroup findings in any major trial, for a trial in which the overall result for the primary outcome is neutral or negative, such considerations are often misleading, since the potential for harm is often implied for the partner subgroups. Such qualitative interactions are rarely plausible (unless a strong mechanistic underpinning is present), and the analyses are typically not adjusted for multiple comparisons; even if the findings from statistical tests of interaction are significant, such findings should usually be perceived as useful for generating hypotheses at best. Indeed, we find it hard to think of an example in which an apparent benefit in a subgroup in a trial with a negative outcome has led to a confirmation in a subsequent trial.”"
It's time to investigate sunspotter and your ulterior motives. These authors have dedicated their lives to the field of medicine and are highly reputable authorities in the field, and you, the anonymous internet board poster, are saying that you know better than them. Your only credential is posting thousands of messages on an internet stock board. Look up their bios. You don't have 1% of the knowledge of liver disease compared to these authorities in the field. It is extremely arrogant of you to slander their names that like. I guess you can only do that hiding anonymously behind a keyboard.
Title: Belapectin at 2 mg/kg/LBW Reduces Varices Development in MASH Cirrhosis with Portal Hypertension: Results from the NAVIGATE Trial
Abstract Number: LB-006/ LB25183
Session: Poster, Complication of Cirrhosis, Portal Hypertension
Authors: Naim Alkhouri, Raj Vuppalanchi, Mazen Noureddin, Mitchell Shiffman, Eric J. Lawitz, Edward Mena, Nadege Gunn, Khurram Jamil, Stephen A. Harrison, Naga Chalasani
Date, time & location: Saturday, May 10, 2024: 1:00 PM - 2:30 PM, CET RAI Amsterdam
The fact is, those ten “authorities” have allowed their names to be used as authors on an abstract that has a demonstrably false claim in its very title.
As I have demonstrated on numerous occasions.
You should pay attention to the facts, not the spurious claims made by the company and its ghost writers.
The fact is, 10 well respected authorities in liver disease say the drug reduces varices. Look up their bios.
Title: Belapectin at 2 mg/kg/LBW Reduces Varices Development in MASH Cirrhosis with Portal Hypertension: Results from the NAVIGATE Trial
Abstract Number: LB-006/ LB25183
Session: Poster, Complication of Cirrhosis, Portal Hypertension
Authors: Naim Alkhouri, Raj Vuppalanchi, Mazen Noureddin, Mitchell Shiffman, Eric J. Lawitz, Edward Mena, Nadege Gunn, Khurram Jamil, Stephen A. Harrison, Naga Chalasani
Date, time & location: Saturday, May 10, 2024: 1:00 PM - 2:30 PM, CET RAI Amsterdam
Well, that’s bullshit then.
From reading that drivel, you’d never know that the NAVIGATE study demonstrated that belapectin was ineffective .
BTW, how long has PRWP/GALT been a “clinical-stage biotech company”?
Is it 20 years yet?
Rhetorical question - yes, is the answer, and it seems like Jim is getting more and more desperate with each passing year.
Adam Feuerstein called this scam years ago:
https://www.thestreet.com/investing/stocks/biotech-stock-mailbag-aspenbio-10741455
Good article published this week about GALT with lots of knowledgeable details -
https://talkmarkets.com/content/stocks--equities/galectin-therapeutics-is-undervalued-and-with-short-squeeze-underway?post=504960
“ Bottom line is the drug works”
“ Belapectin Misses Primary Endpoint in Phase 3 MASH Cirrhosis, Portal Hypertension Trial”
New FDA priority review program is favorable to GALT.
https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests
The FDA Commissioner will use specific criteria to make the vouchers available to companies that are aligned with the national health priorities of:
Addressing a health crisis in the U.S.
Delivering more innovative cures for the American people.
Addressing unmet public health needs.
Increasing domestic drug manufacturing as a national security issue.
Recommend watching a replay of the presentation from top liver experts
https://lifescievents.com/event/galectin/
Bottom line is the drug works and it is highly likely the market cap will rise accordingly.
Nah, it doesn’t work according to the current trial results.
The NAVIGATE study failed its primary endpoint.
After that, all the secondaries become moot, no matter how much the GALT pimps bleat.
GALT The real actual reason behind the movement
The navigate phase three kol conference on Monday.
If you didn't watch it, it's online
Belapectine trial results clinically show statistically significant reduction in varices
And have no side effects statistically different than placebo.
But that's just the tip of the rocket
check out https://stocktwits.com/symbol/GALT
For more DD and to learn why this stock is moving like it is.
Not here to sell anything, just making sure everyone has a chance to learn why it's happening, when it's happening, and where it's going.
Not here to debate, just providing perspective since...... we'll let's be honest, if you already knew you wouldn't be arguing like this.
We'll See ya on Friday, or not
Your call
But hope so
LOL you obviously have little experience in pharma, or your ulterior motive is getting in the way of objectivity, sunspotter. There are many examples of drugs that had to refine the patient subpopulation that will benefit from the drug, based on prior studies. One such example that I'm sure you've heard of is Keytruda. Another one is the former best selling drug Humira. These drugs had to find the right subgroup stratification after their phase 2 studies. The 10 authors, highly respected liver authorities are putting their names behind the title Reduces Varices Development in MASH Cirrhosis because they understand all the data taken together as demonstrating benefit. If you persuaded anyone to short this stock, they should go after you sunspotter for bad advice.
Title: Belapectin at 2 mg/kg/LBW Reduces Varices Development in MASH Cirrhosis with Portal Hypertension: Results from the NAVIGATE Trial
Abstract Number: LB-006/ LB25183
Session: Poster, Complication of Cirrhosis, Portal Hypertension
Authors: Naim Alkhouri, Raj Vuppalanchi, Mazen Noureddin, Mitchell Shiffman, Eric J. Lawitz, Edward Mena, Nadege Gunn, Khurram Jamil, Stephen A. Harrison, Naga Chalasani
Date, time & location: Saturday, May 10, 2024: 1:00 PM - 2:30 PM, CET RAI Amsterdam
That is your layperson opinion. Like I said, look up the biographies of these highly respected liver authorities. They are looking at the all data taken together, along with their understanding of the disease, to come to this conclusion. They work directly with MASH under the microscope, and in the operating room transplanting livers and fixing bleeding varices. They work directly in designing and assessing the outcomes of clinical trials. You have none of that experience, sunspotter. What we do know is that you are on the keyboard all day posting on a stock board. That doesn't make you qualified.
Title: Belapectin at 2 mg/kg/LBW Reduces Varices Development in MASH Cirrhosis with Portal Hypertension: Results from the NAVIGATE Trial
Abstract Number: LB-006/ LB25183
Session: Poster, Complication of Cirrhosis, Portal Hypertension
Authors: Naim Alkhouri, Raj Vuppalanchi, Mazen Noureddin, Mitchell Shiffman, Eric J. Lawitz, Edward Mena, Nadege Gunn, Khurram Jamil, Stephen A. Harrison, Naga Chalasani
Date, time & location: Saturday, May 10, 2024: 1:00 PM - 2:30 PM, CET RAI Amsterdam
"Are you talking about MDGL's drug?"
Are you a supporter of the competitor MDGL?
"you have to falsely claim that the worlds respected liver disease authorities are liars"
It's time for us to investigate your ulterior motive, sunspotter. You just stated "I have been closely associated with one very successful drug used in liver disease." Are you talking about MDGL's drug? Are you a supporter of the competitor MDGL? That would explain why you are determined to take down the competition even if it means you have to falsely claim that the worlds respected liver disease authorities are liars.
Title: Belapectin at 2 mg/kg/LBW Reduces Varices Development in MASH Cirrhosis with Portal Hypertension: Results from the NAVIGATE Trial
Abstract Number: LB-006/ LB25183
Session: Poster, Complication of Cirrhosis, Portal Hypertension
Authors: Naim Alkhouri, Raj Vuppalanchi, Mazen Noureddin, Mitchell Shiffman, Eric J. Lawitz, Edward Mena, Nadege Gunn, Khurram Jamil, Stephen A. Harrison, Naga Chalasani
Date, time & location: Saturday, May 10, 2024: 1:00 PM - 2:30 PM, CET RAI Amsterdam
“ The title is not disputable by a layperson such as yourself sunspotter.”
“ If you are saying they made a false claim”
The title is clear. There is enough evidence for 10 highly respected liver disease experts to make the claim that belapectin reduces varices development. They put their names behind the title. If you are saying they made a false claim, you are getting yourself into potential jeopardy going up against people who will be very interested in defending their reputation.
There is plenty of scientific evidence spanning multiple trials. There is new FibroScan data further validating the results. You are obviously not aware of developments with this company and you just have an ulterior bashing agenda to say any nonsensical things.
Title: Belapectin at 2 mg/kg/LBW Reduces Varices Development in MASH Cirrhosis with Portal Hypertension: Results from the NAVIGATE Trial
Abstract Number: LB-006/ LB25183
Session: Poster, Complication of Cirrhosis, Portal Hypertension
Authors: Naim Alkhouri, Raj Vuppalanchi, Mazen Noureddin, Mitchell Shiffman, Eric J. Lawitz, Edward Mena, Nadege Gunn, Khurram Jamil, Stephen A. Harrison, Naga Chalasani
Date, time & location: Saturday, May 10, 2024: 1:00 PM - 2:30 PM, CET RAI Amsterdam
For the last time, it doesn’t matter how many authors or physicians (or PRWP/GALT company pimps) claim that:
“Belapectin at 2 mg/kg/LBW Reduces Varices Development in MASH Cirrhosis”
Wow sunspotter you are trying so hard to counter 10 authors who are well respected authorities in the liver disease field. In the normal publication process, authors agree on the title. The title is very clear and no one can be mistaken on the meaning of the title, including the 10 authors. Now you are accusing them of having a ghost writer, as if they are blind and unaware of the title. With each post you get more ridiculous LOL.
Title: Belapectin at 2 mg/kg/LBW Reduces Varices Development in MASH Cirrhosis with Portal Hypertension: Results from the NAVIGATE Trial
Abstract Number: LB-006/ LB25183
Session: Poster, Complication of Cirrhosis, Portal Hypertension
Authors: Naim Alkhouri, Raj Vuppalanchi, Mazen Noureddin, Mitchell Shiffman, Eric J. Lawitz, Edward Mena, Nadege Gunn, Khurram Jamil, Stephen A. Harrison, Naga Chalasani
Date, time & location: Saturday, May 10, 2024: 1:00 PM - 2:30 PM, CET RAI Amsterdam
“ So can you state it clearly sunspotter, that you are accusing the following authors of lying?”
So can you state it clearly sunspotter, that you are accusing the following authors of lying? Have you looked up their bios? How do you think they will react and what actions they will take against you when they find out you are making this reputation accusation against them?
Authors: Naim Alkhouri, Raj Vuppalanchi, Mazen Noureddin, Mitchell Shiffman, Eric J. Lawitz, Edward Mena, Nadege Gunn, Khurram Jamil, Stephen A. Harrison, Naga Chalasani
Protest and confabulate as much as you like, but this title is simply unscientific and misleading:
“Belapectin at 2 mg/kg/LBW Reduces Varices Development in MASH Cirrhosis with Portal Hypertension”
sunspotter, so now you are accusing 10 authors, who are highly respected in the field of liver disease, of data manipulation? LOL Look up their biographies, the author list is below. You are quite something, trying to spin a narrative that suits your agenda. In the face of all the factual information, you stubbornly stick to making false accusations because you are able to hide behind a message board handle. Sad.
Title: Belapectin at 2 mg/kg/LBW Reduces Varices Development in MASH Cirrhosis with Portal Hypertension: Results from the NAVIGATE Trial
Abstract Number: LB-006/ LB25183
Session: Poster, Complication of Cirrhosis, Portal Hypertension
Authors: Naim Alkhouri, Raj Vuppalanchi, Mazen Noureddin, Mitchell Shiffman, Eric J. Lawitz, Edward Mena, Nadege Gunn, Khurram Jamil, Stephen A. Harrison, Naga Chalasani
Date, time & location: Saturday, May 10, 2024: 1:00 PM - 2:30 PM, CET RAI Amsterdam
"It is laughable that a person with no medical training such as yourself has the gall to deny the collective conclusions for these 10 highly respected medical scientists."
LOL this conversation is revealing more about you, sunspotter, than it is about the company. Specifically you have an ulterior motive grudge that you are holding onto for several years that you won't let go of, despite the positive evidence in favor of the company.
So what if the original angel investor still holds a lot of shares. Apparently he hasn't sold, which is good. The fact is that he has zero involvement in the company for the past several years. He's not even on the board anymore. If this is your big swipe against the company, you are really grasping for straws.
In the rest of your post you are disputing the conclusions of the 10 authors who are highly respected, not just in the US but they are internationally recognized authorities in treatment for liver disease. It is laughable that a person with no medical training such as yourself has the gall to deny the collective conclusions for these 10 highly respected medical scientists.
LOL we are learning about you sunspotter.
"Mr. Czirr provided funding more than a decade ago through his equity fund and has not been involved in the company in any way for many years since that time."
"These authors reputations for medical and scientific truth will far exceed that of an anonymous internet board poster on a stock board."
"Title: Belapectin at 2 mg/kg/LBW Reduces Varices Development in MASH Cirrhosis with Portal Hypertension: Results from the NAVIGATE Trial"
"Secondary endpoints cannot be validly analyzed if the primary endpoint does not demonstrate clear statistical significance"
"Belapectin Misses Primary Endpoint in Phase 3 MASH Cirrhosis, Portal Hypertension Trial"
subspotter first of all this shows how little you know about the company, because you don't even know who's involved. Mr. Czirr provided funding more than a decade ago through his equity fund and has not been involved in the company in any way for many years since that time. You cannot take away from the medical advance because you have some beef with someone from a decade ago. This is completely irrelevant, because this equity fundraiser is not involved with the company in any way whatsoever in recent years.
Take a look at these medical authors credentials and then tell us if you are accusing these authors of untruths. Look up each of their biographies. These authors reputations for medical and scientific truth will far exceed that of an anonymous internet board poster on a stock board.
Title: Belapectin at 2 mg/kg/LBW Reduces Varices Development in MASH Cirrhosis with Portal Hypertension: Results from the NAVIGATE Trial
Abstract Number: LB-006/ LB25183
Session: Poster, Complication of Cirrhosis, Portal Hypertension
Authors: Naim Alkhouri, Raj Vuppalanchi, Mazen Noureddin, Mitchell Shiffman, Eric J. Lawitz, Edward Mena, Nadege Gunn, Khurram Jamil, Stephen A. Harrison, Naga Chalasani
Date, time & location: Saturday, May 10, 2024: 1:00 PM - 2:30 PM, CET RAI Amsterdam
Sorry for the losses of those who have fallen for Jim Czirr and his associates' many distortions and untruths over the decades that PRWP/GALT has been hoodwinking its marks.
But while losing money is no doubt painful, that's no reason to resort to incivility and groundless accusations.
"Impressive data"
Mr. Market knows what's going on here.
Mr. Market knows what "not statistically significant" means, understands that you can't omit to mention a whole dosing arm, and also gets that painting new targets around existing bullet holes that missed the original target is the work of conmen and grifters.
Whether you call it PRWP or GALT, this leopard has never changed its spots.
JIm Czirr is a conman who has hired other conmen to do his dirty work for him.
GALT under $2
Sorry, your DD just doesn't cut it. Any statistician would prove your exaggerations are a distortion of reality.
More data dredging, the equivalent of painting targets around already existing bullet holes.
Any statistician with any expertise in life sciences and DB controlled studies will recognise this as a disgraceful and invalid attempt to make a silk purse out of a sow’s ear.
Clearly nothing has changed since the days of fraud during PRWP era:
https://www.thestreet.com/investing/stocks/biotech-stock-mailbag-aspenbio-10741455
No doubt for futility. As it has no discernible clinical effect in actual controlled trials, it’s unlikely to be for toxicity.
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