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Typical short view point. Wish his self promotable material would stop. His charts never work. This is why shorts love his work.
I didn’t see another study for dosing. Just a confirmation of dosing. They still say first patient will be dosed in Q1. So you’re saying the trial will last 6-8 months longer. Traber is still forking the company over long after he’s gone.
And sometimes delay in news means serious delays.
New protocol - another study for dosing - add at least 6-8 months to start final phase 3 - from where the money will come from? Don’t know.
In early biotechs with no revenue - the principle is simple - the CEOs announce good results promptly , bad news is delayed and is tried to combined with some other perceived good news.
Of course it doesn’t
Read the second paragraph
Actually read the PR - the collaboration is for using data from completed trial and not new trial.
The P2 trial was successful so it makes sense. It does not say if the P3 protocol was accepted or there were some open issues.
* * $GALT Video Chart 11-11-19 * *
Link to Video - click here to watch the technical chart video
As far as Siemens goes it looks like Gilead is out and Galectin is in. GILD drug failed twice in PHASE 3.
News: $GALT Galectin Therapeutics Reaches Agreement with Siemens Healthineers to Collaborate on NASH and Liver Fibrosis
NORCROSS, Ga., Nov. 11, 2019 (GLOBE NEWSWIRE) -- Today, Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, announced a collaboration agreement with Siemens Healthineers, a global leader in medical technology, in nonalcoholic steat...
Find out more GALT - Galectin Therapeutics Reaches Agreement with Siemens Healthineers to Collaborate on NASH and Liver Fibrosis
Yeah, why would they agree to this BEFORE the phase 3 was set ?
I'm sure Siemens doesn't
Siemens think that too???
That’s exactly what I thought. That’s exactly what I expect given my investment results.
The delay in announcement seems to indicate that the protocol is not approved.
The 10-q for sept end should come next week and they will have to give business update. The protocol approval is the only activity going on in GALT - so we need some update
Sorry, 95 on Saturday.
85, 90 ... We have 85, 90 on Saturday ....
Giving advice to sell is sign of cult follower - not an investor who asks questions to verify progress
Very bad for the company
- topline results announced in Dec 2017
- the phase 3 not started even after 2 years
- the P3 protocol is not yet approved by FDA after 80 days - also co has not issued any update - seems FDA has sent the protocol back for changes
“Galectin Therapeutics announced top-line results from its NASH-CX Phase 2 trial in December 2017. The Company is proceeding with plans for its NASH-RX Phase 3 clinical trial program with its galectin-3 inhibitor belapectin (GR-MD-02) in NASH cirrhosis. Plans for the NASH-RX trial were put forward in August via a Type C Written Response Only submission to the U.S. Food and Drug Administration (FDA) with the goal of finalizing the protocol and initiating the clinical trial in the near future”
80 days, do I hear 85 days ? Going once ...
It’s public info - we will know
GALT doesn’t care whether we know about this or not.
I believe a response is required by FDA by then
Is 75 days official guideline? Cannot find any documentation
The 75 days are not up yet
These guidelines aren't 'favorable' at all for GALT since they focus on Clinical Outcomes, regardless of source, and not progression to Varices.
GALT's original plan was for the Ph3 to have a primary endpoint relating strictly to either reduction in HPVG or the progression to varices. The change to clinical outcomes adds other elements to the discussion that will affect the results since none of them will be helped by GR-MD-02.
Just look at slide 17 from July, 2018 regarding this: https://investor.galectintherapeutics.com/static-files/d114ffca-2367-48a2-99cc-ec0292d18fe1
This change by the FDA is the reason, IMO, why it has taken so long for GALT to finalize the Ph3 protocol.
Is no one interested ? It appears that way.
75 days would be .... tomorrow ? Sweet dreams.
Here are NASH-CX trial protocol guidelines for P3 - there were written in Jun 2019 as if specifically for GALT.
Not sure anyone is close to P3.
One can see that the inclusion - exclusion
Criteria are stringent - enrollment will be expensive and long process.
https://www.fda.gov/media/127738/download
Interesting report - out of $18 B potential market 62% is for NASH - CX and GALT is only co with P3 ready drug. It is very attractive and overdue to get P3 approved by FDA
https://www.globaldata.com/global-nash-market-set-reach-18-3bn-2026/
“The total size of the non-alcoholic steatohepatitis (NASH) market across the 7MM* is set to grow from $138.4M in 2016 to $18.3bn in 2026 at a compound annual growth rate (CAGR) of 63%, according to GlobalData, a leading data and analytics company.
GlobalData’s report also finds that drugs which are proven to benefit NASH patients with cirrhosis will account for the largest segment of the NASH market. The company expects these drugs to account for 62% of the NASH market in 2026, with total sales of $11.3bn.”
The First step is the notice to proceed from the FDA. So I am definitely looking forward to that news like now or maybe next week. They said the beginning of October which is 60 days from their announcement in July. The FDA is required to respond to their letter.
I am hoping something like this deal - not just fda acceptance.
The fda acceptance is just start of trial and it will possibly go for at least 2 more years. So some BP should do the same deal as below
https://finance.yahoo.com/news/akcea-pfizer-inc-announce-licensing-105000501.html
I got from the business update
Galectin Therapeutics Reports Q2 2019 Financial Results and Provides Business Update $GALT https://seekingalpha.com/pr/17599579
I see no news to support a 9% jump in price this morning. Rumour of FDA acceptance of the trial protocol maybe? What have other companies spent on Phase 3 NASH? Will $40-50 million be enough to go alone on this?
It looks like some are buying the rumour of something. FDA acceptance of Phase 3 protocol maybe.
where do you get $44 million on hand? The June 30 Q10 stated $52 million. Did you reduce that figure by the burn rate? Also they have only S3 registered 1.7 million shares at maximum price of $3.51 for additional $6 million. Seems like very mild dilution for a company with 56.6 million shares outstanding. If your figures are correct of $44 million that would put cash back to $50 million.
The phase 3 protocol was submitted on Aug 5th - this weekend it will be 2 months.
Typically the protocol gets approved in this time.
Is there query from FDA on trial details? Company normally sends updates quickly.
This is long term play if they go alone - I am expecting a partnership or BO as they possibly run the trial alone.
500 patients -11 countries - 128 sites
12-14 month enrollment + 24 months from last patients for results - results in 2022
no interim readout
Very long road and only $44 million on hand
On other hand only Phase 3 NASH-CX trial on horizon - in reality only NASH-CX product to talk about.
My hope and expectation is - One of the top BP - BMY-MRK-PFE-Gild can just pay $50-100 million and lock them into collaboration
The only other P3 independent target is MDGL - trial started with end date 2024. The mc is $1.50 Billion + but it is in NASH-FX where few more BP players
So hoping that once protocol is approved - we may see collaboration and SP does not go below $2.50
Thanks for your insight. You sound like a really cool guy!
I bought 5,000 shares of GALT around this time in 2017 for under $2 and sold 4,500 when it broke above $8.50. I’ve been holding the balance ever since. This stock has big upside potential with key trials in the works, but it may take several months maybe 1-2 years before huge gains will be made (in my opinion). Looking to add again at the $1-$2 range and set my order to sell again at $8.50. This time I may hold on to more shares long-term depending on the fundamentals at that time.
This stock Has My Attention .
Took some nice gains on others companies I bought into . On several I'm
going to hold long term shares as well . I recently found this one and find
it most interesting . I like this price . Obviously on the edge of a breakthrough
without side effects . They need financing and will probably solve that . I see
insiders put their money where there mouth is and thats a great sign . Who
on this board owns this and please add to this discussion . I'm sure I will add
this stock to my portfolio and soon . Thank you
The science hasn’t helped CYDY. That’s why I’m here instead. Maybe I made the same mistake twice.
They are clearly going to have another update in the next 2 months. They said they submitted the FDA filing.
Management clearly has some issues with communications but the technology is sound so despite inept management this stock should be worth 500 million or more.
If you are long term oriented. Believe in the science it will not fail you.
Galectin Therapeutics a Potential $10 Billion Buyout, still valid?
https://emerginggrowth.com/galectin-therapeutics-inc-nasdaq-galt-a-potential-10-billion-buyout/
Biotechs' Second-Half Battle
https://seekingalpha.com/article/4276463-biotechs-second-half-battle
Agree - they are ahead of everyone in terms NASH-CX - literally no one is near where they are - no drug with P3 ready and good safety and P2 results.
Question of starting the P3 trial and/or convincing BP about their product so they collaborate or buy them out.
These trials are very long - long period of enrollment and min 48 weeks for efficacy - with many other companies, GLMD, MDGL, VKTX, GILD starting P2/P3 trials, NASH patients have high demand - it is very competitive. I would rather have some BP buy this co, let me make money even if not huge and move on.
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