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The upcoming cohort 2 results will contain FibroScan, when it shows the 6 people tested have some degree of reversal
I have found it difficult to find solid stats on the overall approval rates for fast track.
If all are getting eventual approval, it would be hard to lose by implying strategy of investing in Fast Track companies.
Quote:
"I have been told by someone in a position to know what is going on with GALT that every drug given Fast Track designation has eventually been approved by the FDA. This is a very powerful statement. "
Everything goes well GALT will be getting a $650 target before the end of 2015.
Quote:
"Intercept rises after analyst targets shares to more than double
Shares of drugmaker Intercept Pharmaceuticals (ICPT) are climbing after research firm Summer Street initiated coverage of the shares with a Buy rating and a $650 price target in a note to investors earlier today."
http://www.theflyonthewall.com/permalinks/entry.php/ICPT;GALTid2011988/ICPT;GALT-Intercept-rises-after-analyst-targets-shares-to-more-than-double
After he saw the Cohort 1 results, he would have switched from scam to getting product to market. Way more money in it than scam.
GALT has made big moves in the past. I wouldn't want to be on wrong side of that short.
You are looking at what the timing would be under regular approval. GALT is not going to speculate and post on its website on accelerated approval times.
Quote:
Drugs
HomeDrugsResources for YouInformation for Healthcare Professionals (Drugs)
Resources for You
Information for Healthcare Professionals (Drugs)
FDA Drug Info Rounds
Global Alliance of Drug Information Specialists (GADIS)
Drug Safety Information
-
Transcript: Accelerated Approval Program video
Return to Accelerated Approval Program page
Captain Mary Kremzner: When it comes to treating serious or life-threatening diseases, speeding drug development and delivery is in everyone's interest. The Accelerated Approval Program is one way the FDA helps make new, potentially lifesaving drugs available more quickly. Hi, I'm Captain Mary Kremzner and this is Drug Info Rounds brought to you by the pharmacists in the FDA's Division of Drug Information. I'm joined by FDA pharmacist, Commander Catherine Chew, who will examine the Accelerated Approval process and what it means for the medical community. Cat, can you provide a little context about the origins and intentions of the program?
Commander Catherine Chew: Absolutely. When starting a new drug, Mary, as you know it can take a very long time, oftentimes several years, to definitely demonstrate a clinical benefit and then go through the process of securing FDA approval. In 1992 the FDA instituted its Accelerated Approval Program as a way to speed new drugs to market that treat serious diseases and fill an unmet medical need.
Captain Mary Kremzner: Now Cat, exactly how does the FDA determine when an expedited approval is warranted?
Commander Catherine Chew: Generally drugs are approved under Accelerated Approval if they have the potential to impact factors, things like survival, day-to-day function or the likelihood of stopping a disease from progressing and becoming an even more serious condition.
Captain Mary Kremzner: Now Cat earlier you mentioned filling an unmet medical need. How would you define that?
Commander Catherine Chew: An unmet medical need simply means providing a therapy when none exists or providing a new therapy that may be superior to or less toxic than an existing one.
Captain Mary Kremzner: So without the standard clinical outcomes how does FDA determine if a treatment is potentially effective?
Commander Catherine Chew: Great question Mary. Accelerated Approvals use what we call a surrogate end point in clinical trials. These are markers or a physical sign of sorts used as an indirect measurement to predict a clinically meaningful outcome like survival or symptom improvement.
Captain Mary Kremzner: So exactly how does the surrogate end point save time in the drug approval process?
Commander Catherine Chew: Well for example, instead of having to wait to learn if a drug prolonged survival in cancer patients the FDA has approved drugs based on evidence that they shrink tumors. As a surrogate end point, tumor shrinkage is reasonably linked to real clinical benefit.
Captain Mary Kremzner: Okay, so let me make sure I have this. Let’s say a drug goes through Accelerated Approval and gets to market, how do we know if it really provides that clinical benefit?
Commander Catherine Chew: Any approvals given based on surrogate end points are on the condition that the sponsor will conduct post-marketing clinical trials to verify the anticipated benefit. If these trials, called Phase 4 Confirmatory Trials, shows the drug does in fact provide a clinical benefit then and only then does the FDA grant traditional approval for that drug.
Captain Mary Kremzner: Worst case scenario, Cat, what if the drug fails to prove that clinical benefit?
Commander Catherine Chew: In that case the FDA has a series of regulatory procedures in place that could eventually lead to the drug’s removal from the market.
Captain Mary Kremzner: The Accelerated Approval Program strikes just the right balance between safety and speed which can make all the difference to patients with serious or life-threatening diseases. If you have questions about the Accelerated Approval Program, call or email the FDA’s Division of Drug Information.
http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm313852.htm
Bradfor123 I think you are missing the understanding of what fast track is and what it's goal is.
After any review the FDA can grant approval under fast track. The company is still required to complete all phases. If there is a failure along the way the approval can be pulled. Many times approval is given for compassionate use only. About 50% of the drugs that get approval under fast track get it after the first review. This typically occurs in Phase2. It is very rare for a drug to receive fast track in phase1.
So the first review of phase2 would seem to be the earliest but since GALT has fast track now anything is possible if the FDA likes what they see.
After the Market reaction to these results I will not even guess where the price will go after good cohort2 results. One thing is almost for sure, the results show with high% that the animal studies have translated to humans. I believe a lot of the risk went away yesterday. For those who didn't see that and sold they will be kicking themselves the day when GALT's price reflects its technology.
By the market reaction today I think you will have lots of time to pick up shares at these levels. Looks like no Market valve increase in good phase1 data. Looking like phase2 data required to have a real effect on SP.
All the Calls I have are almost worthless, down 80%+ from yesterday. Hopefully they bounce back a bit. Happy now I only purchased half as many as I was planning to.
MLV did not raise the price target still at $20.00
Quote:
In a report published Tuesday, MLV & Co analyst Vernon T. Bernardino reiterated a Buy rating and $20.00 price target on Galectin Therapeutics (NASDAQ: GALT).
In the report, MLV & Co noted, “Albeit from 8 patients, an abundance of data support the safety and positive effects of GR-MD-02 on the major pathological processes observed in NASH. Next steps include dosing at 4mg/kg, adding FibroScan, an FDA-approved ultrasonic measure of liver tissue elasticity, to cohort 2 protocol. We continue to expect positive results in cohort 2 (expected Jul-Aug 2014).”
Galectin Therapeutics closed on Monday at $15.31.
http://m.benzinga.com/article/4435858?utm_referrer=http%3A%2F%2Fnews.google.com%2F
Yes the sheep need a Shepard.
Yes that's what I though all along where GALT would become a multi billion market cap, from the FibroScan. Still the Fibrotest has proven to be very accurate. Watching after hours trading is disappointing.
FibroScan with Fibrotest gives more complete accurate results than biopsies.
I think to trust FibroScan or even Fibrotest more than biopsies due to the small sample area.
The best results come from all three, correlation from the biopsy to the FibroScan gives a complete picture.
Results look good to me, shows that it does what it was designed to with a high % of certainty. After hours trading doesn't look to be impressed though.
First Cohort Results in Galectin Therapeutics' Phase 1 Trial Reveal Biomarker Evidence of Therapeutic Effect on Fibrosis and Inflammation in NASH With Advanced Fibrosis
Galectin Therapeutics, Inc.
4 minutes ago
GR-MD-02 was safe and well tolerated in patients
Galectin Therapeutics to host webcast, April 1, 8:30 a.m. EDT to discuss first cohort findings
Second cohort of Phase 1 trial to begin enrollment in April
NORCROSS, Ga., March 31, 2014 (GLOBE NEWSWIRE) -- Galectin Therapeutics (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(TM), 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(TM), 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.
About Fatty Liver Disease with Advanced Fibrosis
Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity rates, estimated to affect nine to 15 million people, including children, in the U.S. Fatty liver disease is characterized by the presence of fat in the liver along with inflammation and damage in people who drink little or no alcohol. Over time, patients with fatty liver disease can develop fibrosis, or scarring of the liver, and it is estimated that as many as three million individuals will develop cirrhosis, a severe liver disease where liver transplantation is the only current treatment available. Approximately 6,300 liver transplants are done on an annual basis in the U.S. There are no drug therapies approved for the treatment of liver fibrosis.
About Galectin Therapeutics
Galectin Therapeutics (GALT) is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company's unique understanding of galectin proteins, key mediators of biologic function. We are leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. We are pursuing a clear development pathway to clinical enhancement and commercialization for our lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.
Forward Looking Statements
This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as "may," "estimate," "could," "expect" and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. These statements include those regarding the clinical trial, including the expected timing of results for the second cohort, and potential benefits and therapeutic effects of GR-MD-02. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that we may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of GR-MD-02 or any of our other drugs in development. Our current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could prove time consuming and costly. We may have difficulty enrolling new patients, which could impact timing and costs. Results from the first cohort of Phase 1 are not necessarily indicative of future results in the clinical trial. Plans regarding development, approval and marketing of any of our drugs are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. Regardless of the results of any of our development programs, we may be unsuccessful in developing partnerships with other companies that would allow us to further develop and/or fund any studies or trials. To date, we have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be impacted by our ability to manage costs and finance our continuing operations For a discussion of additional factors impacting our business, see our Annual Report on Form 10-K for the year ended December 31, 2013, and our subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.
Contact:
Galectin Therapeutics Inc.
Peter G. Traber, MD, 678-620-3186
President, CEO, & CMO
ir@galectintherapeutics.com
Picked up a few more calls myself. We will know soon
Knowing when and how much to sell, I believe is relative to the size of your position and the current share price to expected price/time.
I have noticed that GALT's big runs have taken place over 2 days.
I am expecting good, maybe great results. My guess is the top comes in on the second day, I will be selling some maybe up to 80-90% depending on the SP. ( if bad or not so good sell first day, maybe buy back in second or third day depending on results )
They are planning to raise some more cash, so I believe you should have a chance to sell some in the first week and get back in later for cheaper. ( you never know though anything can happen under fast track. The reason for need for more cash I think phase1 will be ending early to start phase2 )
I think if good results you see GALT apply for breakthrough designation before the end of phase1
Quote:
Darwinian said
I guess I'm pointing this out because I've been thinking a lot about when to "get out" of GALT. It would be tempting to me to take whatever profits present themselves early on but I'd be afraid of missing out on later potential.
Apple tends to due that a lot, start typing and it finishes for you, with the wrong word. Guess I should be more careful.
Thanks for clarifying
ICPT shows us that the market considers NASH treatment to be worth 8 to 9 billion market cap currently. That would put GALT's pps 400 to 500 range if successful in gaining efficiency.
There is also the Cancer treatments to consider. That would add to the value, so 600+ is in range.
Results from first cohort are due the first week of April. Any sign of efficiency and GALT will be catapulted to new levels.
With the first cohort started with dose typically seen in third cohort dose, you have to consider the odds of seeing some efficiency higher than average.
Either way doesn't matter for me. Come the first week of April we should get results.........
I am not surprised by the TA and movement through window. Was thinking with the timing and possibility of hitting triple digit pps with good results, that the price would be hitting the upper ranges, above 17 by now.
I am a little surprised the pps is not higher than it is. Only a little over a week until results. Next week could be last chance to get in at these levels, of course it can go the other way, down also with poor results. I think there are many people watching and employing the other strategy of waiting for results before buying. A smart safer way to invest in biotech. Limit your chance of losses but also limiting gains due to buying at higher levels.
That's a good strategy, the higher the SP goes the larger % gain you will see from GALTW compared to GALT.
Today looked like good day to pick up some Calls. Almost all the volume today on the 20, 25 & 30 April calls was me :)
If the price of GALT doesn't make a move up over the next few weeks the Calls will start to get really cheap. I will be watching closely to see if some really good deals present themselves.
If we have "good news" meaning some efficiency shown this stock will be a lot more than 25.
Quote:
Bradfor said
seems to be resistance at $ 15 hopefully will not drop below that or if it does not by much I am eagerly waiting news of trials if good news could shoot up to $ 25 quite quickly who knows
That sounds like a plan that will work.
Reading something like investing for dummies, should give you some more confidence with your transactions.
Calls are very risky, in this case the odds look much better than average.
JMHO
Quote:
Darwinian said
Are you saying I should by 20 or more calls and then sell back all of them (when the price goes up) except for the five I want to exercise to help pay for those 5?
I don't know 6 to 8 in bigger is better for our bio friends.
Most seem to be capable of 20x's+. Maybe I am to lazy to track more that 8 haha.
Tom said:
I'm also thinking about tightening the portfolio and only keeping the handful that are really the best. Not less than 10 but around a dozen stocks. I don't feel comfortable putting everything into just 3. that seems too risky to me.
Darwinian you seem to have a flow of continued investment income. Not like you will quit if you lose here. what are calls if you Lose to ratio of total to upside. My perspective is I have increase 10% of GALT investment for call if I want. You can still sell some to double at 10% of current.
Like I say before increase of 2x to 3x maybe more is not bad decision. Have to look at % to income and give a sh$t, you are behind is better to take risk now.
The true end result is how much you work till retire. Maybe never if you risk to much.
If you stay to the calls you can never loose more than you put in.
In our age group there has to be a ratio of risk to day when you cut the kids loose or cut any other expense.
Hay Tom life is short but many year trying. Time is here I don't known but GALT feels right maybe we take 100x's from start :)
I was looking what One could buy with cash out. Thinking if I had XXX. Would I put it all in GALT? Seems like I should take some profit. Or thinking new money for 10% of new calls is smart maybe smarter.
I alway find no regrets is best. Still trying to figure out that line for GALT
From Darwin post on, modified citrus pectin or my post on
Hydrolyzed collagen a collagen. It is also called collagen hydrolysate, collagen peptide, gelatine, gelatine hydrolysate and hydrolyzed gelatine. Are all related in carbohydrate to protein ratio and its its effect on the body.
As I stated before in so many words. There is direct effect of carbohydrate to protein ratio and how it affects your body. NASH is sadly mostly self induced.
Darwinian maybe I am a bit crazy with risk I am willing to take. We are about the same age.. Should have more than I do but such is life. Learn from the past don't dwell on it.
Selling some or adding 2.5% to 10% to take control of 20 calls for 25 to 100 sounds like a good idea if you think the stock will hit 22 or more from the cohort1 results.
Calls are the most simple of options. What you read for explanation on web should be correct and fairly simple to understand.
There is old sex joke about in out repeat if necessary.
That would be my plan with the apr calls.
Thanks Tom read your post on other boards also. I tend to accumulate more than anything. Keep it coming very useful.
Familyman thanks for follow up, I kinda post off the cuff, a little slow and don't complete on all the info just throw a little bone.
This is a great board. Like you say before Tom no crazy cheerleading (really the only board i post on)
Not like the war zone on NNVC funny but any post I make there gets deleted haha.
GALT board is my speed I hate to be rushed.
New investors should read Biotech2010 posts. A lot of them get rehashed, showing proof though others DD.
Not that I am saying buy because of what you read here. That would be foolish.
You have to decide yourself what to do, the more DD you do the easier the decision.
Of course the price will drop if it is found not to work in humans. There will NOT be enough information from cohort 1 to PROVE it does NOT work, it can be increased 100x's+ from first dose. There is enough contained in cohort 1 to Show 90%+ that it does work.
And there is no hype GALT always has been and still is under the Radar. I believe more than one of us believe this stock should be worth $40+ now.
For a starting point
I would suggest look over all the posts on this board from the beginning.
Read everything from the web site.
Understand why Fast track is important.
Short timer here now 34 days or less for results.
The count down is on:)
Quote:
Bradfort123 said
123tom your info is fantastic but what is your agenda not many try to help others with info please do not take it the wrong way I mean no offense . Do you believe that the product will reverse advance fibrosis and cirrhosis or is this just over hype which could drop like a stone in roughly a month when some cohort 1 information is released if proven not to work in a human trial ? . I would appreciate your thoughts 123tom . I am new to this forum but some great info .
GALT has plans to Start Phase2 Q4 2014 that typically means end of the Quarter. We will have cohort 2 & possibly cohort 3 results by Oct. Calls.
If you look at Apr 20 Calls 1.9 & the stock at 16.8
16.8/1.9=8.8
20+1.9=21.9
Therefore
For every dollar over 21.9 you will see a increase 8.8.
You do realize you sell when you want before expire. You don't have to pay the strike price but you may want to increase share count.
21.9/16.8=1.3. 30% increase from current and you start making money at 8.8x's -30% of the buy price. It has a floating effect depending on what you use for a expected price and if you pay the strike to convert shares or sell.
For basic example for comparison of Calls
100 shares cost 1685 let's say the stock goes to 25, you now have 2500/1685 = 1.48
1 call 100 share 190
25-21.9=3.1/1.9 = 1.68 x 1685/190= 14.9
The Oct 20
16.8/4.6=3.65
20+4.6=24.6.............
Simple quick math. Maybe help find what Call suits your risk reward and fundamental expectation timeline.
I have no interest in the Oct calls. The April 20 mixed with 25 & 30 look good to me.
I see kidney. La Jolla is behind GALT on NASH
http://ljpc.com/product-pipeline/overview/
Quote:
Danwinian said
their NASH trial results are out just before GALT's
What do you about DAVANAT?
It is one reason confidence is high for liver trial results.
http://www.wikinvest.com/stock/Pro-Pharmaceuticals_(PRW)/Davanat
http://www.businesswire.com/news/home/20080129005433/en/Pro-Pharmaceuticals-Phase-II-Trial-Shows-DAVANAT-Improves#.UxH90cu9KSM
http://www.clinicaltrials.gov/ct2/show/record/NCT00110721?term=Davfu003&rank=1
Tom,
Great Lakes Gelatin. There are other supplier all the same. Hydrolyzed collagen. Great stuff me and the wife been taking for years. Mix with coffee, soup whatever. You will live easier or longer if your digestive system has less work to do. Plus anti-inflam & good clean efficient protein. Part of simple no TOX diet. Below ground veg, fruit & meat (all clean from local supply) no Food from large chain. Know your supplier.
Avoid complex chemicals in your diet. Simple logic says no brainier but millions induce resistance with TOX into the system through diet. Than attempt to cure with further toxins??
Snake oil. They call our bio's.
Simple to see most people EAT snake oil and buy more snake oil. try to fix it, you might need some more snake oil to fix the last snake oil or even better mix a shit load together and see what happens. Don't worry I sure you will feel better, if you don't maybe you like to try some new ones we just got in........
I was about to stumble in the back door when,
I found GALT through side door with Cox.
It's much better if there is no resistance in the system.
Acceptable efficiency is clearly reached in higher X's.
Easier for something to flow at less resistance. Ohms law. Or same as f=pa. All translates from electric to hydraulic to mechanic, and basic principal down to quantum physics.
Your body is the same way.
This is basic fundamental logic relationship ratio understanding of GALT.
http://www.greatlakesgelatin.com/consumer/index.php
You might find some deals in the 12.5 Apr Calls on the pull back next week. A safe Call I guess.
Not sure of your risk to give a fuct ratio is.
I sure by time we get results I will double my share count with Calls. You could go more if you want. Not sure myself, maybe 2x or 3x more is cheap if you stay in the 20, 25, 30.
http://ca.finance.yahoo.com/q/op?s=GALT&m=2014-04
You look to be pretty committed to GALT and said you wanted to catch up. You can call your broker get him do it for you just cost you more than online. Just make sure you understand what you are buying. You would not want to short it by accident.
I don't know if its out of your comfort level.
The April 20 & 30 calls are a way to gain a lot of leverage.
Results will be out before then. You sell some shares you have now to pay for the calls.
You don't have to take the calls if the stock goes down, you just lose what you paid for the call.
If all the results show is safety there is no way GALT will not be double of what it is now.
Your 50 share bid would get you about 850 calls. 17 x 1.