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Is there really such a class action being contemplated? If so, I would like to sign up as a plaintiff. Which attorney is leading this effort?
Stockbuilder said...
Yes,correct, the plaintiffs in the class action lawsuit against PT, SA, and associates.
I agree that this is an aggravating factor. This compensation scheme encourages outlandish assertions that drive those "clicks".
Detonate said...
What I see as a flaw in your argument is the fact that Seeking Alpha compensates authors on a "per click" basis. Imo, this alters the landscape a great deal.
Is there no room in the media universe for a "publisher" who offers readers unsolicited, unedited material for which the publisher provides neither compensation nor voucher...essentially providing a blank page to an anonymous author and a disclaimer as to the truth of any content? Doesn't that satisfactorily shift the onus to the reader to ascribe whatever degree of truth or falsity to the material that the reader himself deems appropriate?
It would seem that the plaintiff has a right to determine if the author was operating within SA's "Terms of Use" and "Rules of Conduct". The plaintiff may also be interested to learn whether SA is now or has ever enforced either of those documents.
Detonate said...
There are multiple instances where Seeking Alpha's policy seems to contradict itself. The gist of SA's Terms of Use (TOU) seems to be for the purpose of insulating themselves from any legal repercussions an author may face.
- You may not write about a stock with the intention to boost or reduce the stock's price and sell (or buy) the stock into the resulting strength or weakness.
- If you intend at the time or writing to sell or buy a stock within three days of publication of a User Submission that discusses that stock, you must disclose this.
From Seeking Alpha's Terms of Use/8. User Submissions; Online Rules of Conduct. seekingalpha.com/page/terms-of-use
There is no room for anonymous and defamatory or malicious publications.
loanranger said...
Is there no room in the media universe for a "publisher" who offers readers unsolicited, unedited material for which the publisher provides neither compensation nor voucher...essentially providing a blank page to an anonymous author and a disclaimer as to the truth of any content? Doesn't that satisfactorily shift the onus to the reader to ascribe whatever degree of truth or falsity to the material that the reader himself deems appropriate?
Had someone posted "NanoViricides: House Of Cards With -80% Downside" verbatim on these pages would you be holding this venue to the same standard that you propose for SA? If not, why not?
The current process calls for the allegedly libeled party to establish that there is a reasonable expectation that a finding of libel can be reached prior to a court requiring a publisher in the current circumstance to divulge the identity of an anonymous poster. NNVC has attempted to do that and it's before the court right now. IF the court requires SA to identify the author and SA refuses to do so, I'm sure that that would result in a contempt citation...but I believe that the case against SA for libel would be difficult, even if the printed words were untrue, given the nature of the "publication".
If SA profits from the publication of libelous material, they should be held accountable. This is particularly true if it is determined that SA also profited from shorting the stock of the targeted company. Maybe it is possible that SA can be the honest broker of unaudited information that they apparently claim. However, if they will not allow the author to be held accountable then they should be. Someone must be called to account for libelous, defamatory publications. If SA wants to protect anonymous authors then they can assume full responsibility for the content they publish.
...but its executives have to be held legally accountable for the material they publish. And if they allow unchecked, unedited articles to run under video-game pseudonyms like "Pump Terminator," they should suffer a part of the penalty should the article prove to be libelous.
The company has also "never ever" in it's "over 10 years of history" applied for the breakthrough therapy designation, until now. I think our chances are very good to get the BTD. If I am correct, you only have 10 or 12 days left to play short games. After that, you'll be playing Russian Roulette with your money for the next 30 days. JMHO
Suberized said...
it's never gone too high EVER and that's over 10 years of history.
We could hear back from BTD sooner than 60 days. I believe that the FDA has responded to BTD applications in as little as 30 days. So we could be only 2 weeks away from getting the FDA response.
Dennis 48 said...
There's just no buzz right now... volume is pretty low... we're kind of in a holding pattern for this 60 day BTD waiting period. Some can't stand to hold something for 60 days. Some will bail and be back in what, 45 days or so. No worries.
That was the way I also interpreted those comments.
LutherTiggs said...
How does one interpret this statement from Mullan from the article with respect to the FDA?
“They may say: ‘Look, it is in the food chain, it has been in an awful lot of people. We haven’t had any serious adverse effects directly attributable to it,’ ” Mullan said.
This seems to speak directly to the safety profile. Does this mean that Mullan believes there is a chance that they could move to Phase 2 earlier than 2015?
That's a good article. Thanks.
http://www.heraldtribune.com/article/20140408/ARTICLE/140409674
Could you provide a link to "today's Star/Roskamp news story"?
Knuts4oe said...
Between this 2-hour presentation and today's Star/Roskamp news story, we are seeing the results of a clearly thought out strategy.
@ Robi-1-kenobi - Thank you for assembling this information.
I hope that one of you that is in direct communication with management will send them this information that Robi assembled. I have no confidence that the SEC will address it. Perhaps the chance is greater with the SEC if the company's lawyers are prodding them.
There is also the possibility that this information would be interesting to the Judge that will be hearing the dispute with Seeking Alpha. It does provide support to the argument that PT (and perhaps SA?) participated in an orchestrated effort to manipulate NNVC's share price. That's another reason to send it to management.
The broader market is down. Biotech's are down. I think what we are experiencing must be just the normal inconsistency of the market.
I agree with Biotech2010's comparison to ICPT. Perhaps the small sample size of Cohort 1 may explain the market cap difference between ICPT and GALT? Maybe the "big boys" require a larger sample size before they accept the results as statistically significant?
Also, I have confidence in GALT's management team. But if you think that GALT's management would falsify data or otherwise scam investors, you should probably sell.
bradfor123 said...
If results were better than expected why is this dropping , is it possible the results were made to look better than they really were as this does look strange
Could you please post a link? Thx
This sounds like a very good question for management. Perhaps someone could email this question to them?
Cabel said...
I understand what you are saying but why didn't tehy lead off with B(OM) insatead of B(ABSSSI),..
Bigger market,... no competition,... faster route (mouth rinse),... looks like better results in pre-clinicals.
@govorchin or BK or anyone who knows - I would like to do some more reading on this. Can you provide a link? Mr. Google has not been much help this time. . I am curious not only for CTIX drugs but also for other drug candidates.
govorchin said...
NCI rules state the facility where the trials take place have one day to notify the sponsor if a "cure" is suspected.
Treatment IND - This may be relevant...
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126495.htm
Perhaps you should reveal "what evidence you have" that it will take 5 years for the FDA to approve a drug that already has Fast Track status.
Fast Track also makes the drug eligible for Accelerated Approval and Priority Review. There is also compassionate use. And the results achieved in the compassionate use program can be used to: support the NDA, identify new diseases or conditions for which the drug is efficacious, and/or inform/design future FDA trials. When the drug is proven safe AND efficacious in Phase 1, there is no reason not to get it approved for compassionate use. Once it is actually used to get people off that "death row" liver transplant list, I suspect thing will move pretty fast.
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm
http://www.fda.gov/newsevents/testimony/ucm115209.htm
bradfor123 said...
thefamilyman we are in phase one april 2014 now how it is possible to have fda approved by next year are you kidding me please I am not trying to be rude but what evidence do you have of this.
I disagree. I believe that the Fast Track designation will result in drug approval in 2015. It may well be approved for "compassionate use" this year. No way it takes 5 years with Fast Track already in effect.
bradfor123 said...
yes but to get this fda approved if it does work will not be any sooner than 5 years long way to go , they will need to test many many people
Wait! Today is April Fool's Day! What a relief. I thought this was real...
Why the drop today ? you would at least think it would rise slightly but drop feels strange any thoughts ?
Yes it did "feel strange". But then AF and his buddies swing a big stick. I started getting a bad feeling when he put out that short article last week. In the end, they will lose control of the share price but until then...
bradfor123 said...
Why the drop today ? you would at least think it would rise slightly but drop feels strange any thoughts ?
Looking at the price action this morning is really peaking my curiosity about the outstanding short position. The good thing is that since the announcement was after hours on the last trading day of March, in a few days we will get to see exactly what the short position was going into the announcement.
I certainly agree. Thanks for asking that question. I asked several questions via the web and when I realized that he was probably not going to get to all the questions, I submitted a request that he respond to the remaining questions on their website. His last comments seemed to be a response to that request so there still may be some more info coming later.
biotech2010 said...
I listened to the entire webcast and was the one who asked the question about how the results exceeded expectations.
Dr Traber did a very good job of answering that as well as addressing the new financing shelfs in that they have no imminent plans to sell shares or raise more money.
I don't know if the stock goes up or down from here (the market can be fickle) but this is all positive from a long term view, I have no plans to sell any of my shares.
And, since the Aegis Capital analyst and MLV Analysts got all of the time for questions by phone, I'm guessing one or both of them will reiterate or raise their Buy recommendations shortly.
I was thinking the same thing. I wonder if they will take questions on the call tomorrow morning (or should I say THIS morning.)
Chess Master said...
They crushed the efficacy standards - I wish that they could compare their drug to ICPT or ITMN. GALT has way more biomarkers and data to analyze. If they do a comparison then I think that would be helpful.
Up 84 cents in after hours trading.
Now we see what happens on the conference call.
NORCROSS, Ga., March 31, 2014 (GLOBE NEWSWIRE) -- Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that results from the first cohort of its Phase 1 trial show that GR-MD-02 had an effect on biomarkers that suggest a therapeutic effect on fibrosis, inflammation, and cellular injury. The first-in-man study, which enrolled eight patients in the first cohort, is evaluating the safety, tolerability, and exploratory biomarkers for efficacy for single and multiple doses of its galectin-inhibiting drug GR-MD-02 when administered to patients with fatty liver disease (NASH) with advanced fibrosis.
First cohort results indicate that GR-MD-02 was safe and well tolerated following four doses of 2 mg/kg (80 mg/m2) and there were no serious adverse events. The pharmacokinetics were consistent between individuals and after single and multiple doses with no drug accumulation after multiple doses. In assessing secondary endpoints, it was found that multiple biomarkers of fibrosis and inflammation showed improvement after four doses of GR-MD-02. Additionally, patients with greater evidence of liver cell injury, as indicated by elevated transaminase enzyme levels, had a marked decrease in CK-18, a clinically validated biomarker of cell death. Galectin-3 blood levels, which do not correlate with tissue levels in NASH, were not changed with treatment.
Details of the findings will be discussed by the Company on a webcast and conference call on Tuesday, April 1 at 8:30 a.m. Eastern Daylight Time. The webcast can be accessed at the following link: http://w.on24.com/r.htm?e=773833&s=1&k=A95A6017BF0762550B5252D80F9A24FF. Audio only can be accessed using the following call-in number: 866-219-3563, conference ID 19710441. The presentation is now posted on the Company's website (www.galectintherapeutics.com) for review before the webcast.
"We are extremely pleased with the positive results of the first cohort of our Phase 1 trial, which suggest a role for GR-MD-02 in the treatment of patients with fatty liver disease with advanced fibrosis," said Peter G. Traber, M.D., Chief Executive Officer, President and Chief Medical Officer of Galectin Therapeutics. "Fatty liver disease, characterized by the presence of fat in the liver along with inflammation, over time can develop into fibrosis, or scarring of the liver, which is estimated to affect millions of Americans. Intervention with the intent of reversing the fibrosis is a potentially important therapeutic approach in fatty liver disease, a condition with significant unmet medical need."
The Phase 1 multi-center, blinded (to healthcare providers and patients) clinical trial is being conducted in patients with NASH with advanced fibrosis (Brunt Stage 3) who receive four doses of GR-MD-02 over a 42-day period. Each of the three planned cohorts consists of eight patients, six randomized to receive active drug and two randomized to receive placebo. Eight U.S. clinical sites with extensive experience in clinical trials in liver disease are now active to facilitate rapid enrollment of the second cohort. Trial design details can be found at http://clinicaltrials.gov/ct2/show/NCT01899859?term=gt-020&rank=1.
The second cohort, which will begin enrollment in April, will include an increased dose of GR-MD-02 to 4 mg/kg (160 mg/m2). FibroScan™, an ultrasonic measure of liver tissue elasticity approved by the U.S. Food and Drug Administration, was added to the trial's protocol to provide another assessment of liver fibrosis. For those sites with access to FibroScan™, measurements will be performed at baseline and after the four doses. It is estimated results from the second cohort will be reported in late summer 2014.
GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data has shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.
http://investor.galectintherapeutics.com/releasedetail.cfm?ReleaseID=836644
I bought some more call options today. I hope we are right about this announcement and it's impact on the stock. We will soon know...
GLTAL
Unfortunately when a drug or company has been ridiculed by people (like AF) and the result of that is a 75 to 80% drop in the price of the stock, it apparently does take something like BTD approval to overcome it. Not everyone realizes that AF does not usually deal in actual facts. He depends on the collusion of his short and hedge fund friends to manipulate the share price. He furnishes the FUD and they do the rest. Too bad the SEC doesn't do something to stop it.
Gyroscope said...
is it going to take BTD approval to draw serious attention?
My take on your questions...
123tom said...
Usually Phase 1 positive news is good for share price but its still only phase 1 and shouldn't make it go hyperbolic and stay in the stratosphere...but isn't the fundamental story about GALT , much more rich and successful than simply "phase 1 " safety success....GALT is showing evidence of disease remedy,that would be the kind of thing that yields much greater advancement ...is that correct?
Correct
so they are finishing phase 1,on that level, but they are well along in more advanced development than simply "phase 1 safety trials" Is that the right understanding?
As I understand it, the results next week will be on the 1st Cohort of three planned cohorts. There are still two cohorts, at increased dosage levels, left in GALT's Phase 1 trials.
and so, instead of seeing GALT as simply completing successful 'phase 1' trials....we should be seeing it as an "equal counterpart" with ICPT, same level as ICPT.
is that fair to say?
The answer to this is not so cut and dried. However, the fact that efficacy is a part of GALT's Phase 1 does make it possible to do a better comparative analysis of the two products.
Is GALT associated with ICPT , working with them? having this news conference with them? etc?
No.
Whats the association other than similar research.?
None.
I cannot find where the company has specified when on Monday the information will be released so you may or may not have trading action on Monday before the announcement. From the PR...
Galectin Therapeutics (GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced that on Monday, March 31, 2014, the Company will report results from the first cohort of its Phase 1 clinical trial examining GR-MD-02 in fatty liver disease (NASH) with advanced fibrosis.
so the news is coming after Monday closes... before the announcements...
You may be right. It does appear that the steep decline in ICPT share price has been arrested at about the $330 level.
biotech2010 said...
As for Feuerstein's comments, they are intended to pump ICPT while bashing GALT, plain and simple. ICPT stands to get really hurt if GALT has a best in class drug.
Also, it occurred to me that they already know all this information as it pertains to the previously completed animal studies. It would seem that if these human blood results are comparable to the blood results from the animal studies, then we will know that the drug is performing in humans just as it did in the animals.
There's only one more day to get in before the news is out...
Thank you for your input. And I particularly agree with the statements in bold below. AF is good at insinuating and asserting the importance of things that are irrelevant and immaterial. It is often hard for those of us without the proper scientific background to see through the smokescreen.
I am still concerned about the secondary offering. I would have thought that $37 million would be sufficient to get us to a much higher price point. I was not expecting another offering until we were north of $50 per share, maybe a $100. But then who knows what next week may hold...
Biotech2010 said...
All of this talk about the lack of a liver biopsy is ridiculous, it was never in the trial design.
This is a Phase 1.
The results are obviously very good and no doubt show some reversal of fibrosis based on the biomarkers and metrics stated in the original design.
They will present this on Monday and Tuesday and undoubtedly announce an acceleration of the start of the Phase 2, which will include liver biopsies in the design-there is no other reason for a secondary offering now.
The MLV analyst report states this is a $20 stock strictly with good safety results and a $45 stock if the reported data indicates reversal per the design. This report is far more logical than some bs comment by Feuerstein, who has bashed GALT for years.
Here are the Phase 1 goals, directly from the FDA website:
Primary Outcome Measures: •Primary objective is to characterize safety for GR-MD-02 administered intravenously to subjects w/ biopsy-proven NASH w/ advanced liver fibrosis. Specifically assessed by number of subjects experiencing TEAEs. [ Time Frame: Baseline; Week 1-7 (End of Study); Week 9; Week 11 (Follow-up) ] [ Designated as safety issue: No ]
The primary objective of this study is to characterize the safety, which includes the tolerability and dose-limiting toxicity (DLT), for GR-MD-02 when administered intravenously to subjects with biopsy-proven NASH with advanced liver fibrosis. Specifically, this measure will be assessed by number of subjects experiencing treatment emergent adverse events indicative of DLT.
Secondary Outcome Measures: •A secondary objective is to characterize the first-dose PK profile of GR-MD-02. The PK profile is assessed by the AUC (area under the plasma concentration versus time curve) and Cmax (peak plasma concentration) of GR-MD-02. [ Time Frame: Baseline; Week 1-4 ] [ Designated as safety issue:
•A secondary objective for the study is to characterize the PK profile and serum level accumulation of GR-MD-02 following administration of 3 subsequent weekly doses given by IV infusion beginning 28 days after the first dose. [ Time Frame: Baseline; Week 5-7 (End of Study) ] [ Designated as safety issue: No ]
•A secondary objective is to evaluate change in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), ratio of AST:ALT, alkaline phosphatase, and gamma glutamyl transpeptidase (GGTP); change in AST/platelet ratio index. [ Time Frame: Baseline; Week 7 (End of Study) ] [ Designated as safety issue: No ]
•A secondary objective for this study is to evaluate changes in exploratory pharmacodynamic biomarkers in serum [ Time Frame: Baseline; Week 7 (End of Study) ] [ Designated as safety issue: No ]
A secondary objective for this study is to evaluate levels of exploratory pharmacodynamic biomarkers in serum including galectin-3, inflammatory, cell-death, and fibrosis markers.
Are you saying that those tests are accurate or that they are not accurate?
Bradfor123 said...
Simple ALT & AST test is by means accurate as they
are very sensitive.
The PR said the conference call would be next Tuesday at 8:30am.
AF has published his article. It is not as over the top as others I have read but he does seek to cause doubt about GALT. His key point seems to be that the GALT efficacy data is based on liver enzyme evaluation instead of biopsy results. He implies that end of study biopsy results are what drove the ICPT share price rise. Given that all the GALT study participants have "biopsy confirmed" NASH, it could be that enzyme levels are just an indicator and not "proof positive". If this is not covered on the conference call perhaps someone will ask the question.
From the article...
At the bottom of the list of secondary endpoints is an examination of liver enzyme levels -- ALT and AST -- which I assume Galectin will try to spin as a positive suggestion of the drug's efficacy in NASH. If you're looking for an Intercept-esque demonstration of clinical benefit from GR-MD-02, you won't find it here. The study of Intercept's drug OCA was stopped early for success based on liver biopsies. There are no liver biopsy data in Galectin's phase I study.
Galectin used the delay in announcing the phase I GR-MD-02 NASH data to raise money. In January and February, the company tapped out the $30 million At-The-Market equity finance agreement with MLV & Co. Last Friday, March 21, Galectin filed a new shelf registration statement for the potential sale of up to $100 million in stock. At the same time, Galectin also established another $30 million ATM equity sales agreement with MLV.
ISCO IS SUBLICENSING TO BIOTIME!!!
Believe me, I feel your pain.
I will try to respond to you questions as best I can.
Is the upcoming news only about safety trials (phase 1)
The results coming out Monday are for Cohort 1 of GALT's Phase 1 trial. Safety is always the primary outcome for Phase 1 testing. However, the participants have all been biopsy confirmed to be suffering from NASH. And the study does have efficacy testing as a secondary outcome.
Is GALT more advanced than that?
One reason that GALT was able to start their Phase 1 testing at a potentially efficacious dose is that there was already a substantial amount of testing that had been done for the drug's inclusion in a previous cancer trial. As I understand it, they are not concerned about safety because the drug has proved very safe and well tolerated in previous human testing.
how strong are the fundamentals now?
The company only has 21.9 million shares outstanding and they have $37.6 million dollars in cash ($1.72 per share). They have a drug they know is safe. It is the only drug to ever reverse liver fibrosis in an animal model. It reversed the fibrosis even if they were still administering the toxin that caused the fibrosis (think alcoholics). If it works in humans there is a HUGE market for a drug that reduces the death of people waiting for liver transplants. We have a recent example of the value that the stock market places on the ability to fill this need (ICPT). Given the manner that company officials have and are promoting the up-coming announcement, expectations for good news are understandably high.
what would be the reason why AF hates this stock?
AF and his hedge fund buddies are not good news. I don't know what his game is in this instance but I don't like that guy.
Is his analysis worth considering or is he a game player?
He is definitely a game player. It has been my experience that he will say whatever it takes to accomplish his objective. Even so, he often impacts the price of the companies he targets.
It should be clear enough. GALT's fundamentals are solidor they are questionable. which is it?
I think GALT's fundamentals are solid. But I expect that we will hear a lot of hot air from AF in the coming days. He may wait until the stock advances on the good news and then stage a bear raid. He did that recently with PVCT. PVCT has a good drug and I think PVCT will be a $20 stock this year. But AF and his buddies let the price rise and then staged a bear raid at $6 that drove the price below $2. The stock has recovered to as high as $2.80 and insiders have been big buyers since this happened. The company submitted a BTD app to the FDA yesterday. The FDA response is expected in less than 60 days.
I hope that I will not be the only one to respond to these questions. I am interested in hearing other perspectives.
INCREASING REVENUES WILL GROW THE STOCK PRICE!!!
@mx - It's all good. And the results may be published before the open. I just didn't want you to be disappointed if the results were not published before the open.