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Just give us the "....met its primary endpoint...." headline
If it fails we just have to sit and wait to hear any results on the Melanoma studies. In theory if either of those are successful it sets up a partnership or buyout from either BMY or MRK
"on doing DD on Galt, the molecule for the FX trial readout is 2nd generation compared to first failure"
Is the Ph II GR-MD-02 compound the same as cohort 3 or different, improved?
Thought it was Ph III for PSC, maybe Ph II for NASH, don't recall, yes, it went crazy, some were predicting $800, which would have been $16B+ market cap. If the CX trial is successful GALT should be $10B+ market cap
That was when ICPT was > $400. SRPT got a drug approval, this is just a Ph II readout. Hard to speculate
If data are good $10+ is possible, if data are great $20+ is possible. Hard to speculate, other factors such as what will they do next re: partnerships, trials/dilution, etc.
Of course it could be lousy and that is easy < $1
You mean 200%?
Yes, possibly much more, depends on results and obviously much lower too if poor.
chart means nothing now with the Phase II readout
Yes, not saying what the numbers would be, that depends on the results, time to commercialize, etc. The field is getting more crowded with companies testing therapies so definitely more difficult to accelerate this being so under capitalized. Also, would want to do multiple combination therapies.
Stock to $150+, I'd take that!
I would have a huge # tied to the CX trial.
They could sell like TBRA with the initial payment and a large contingent value right.
Good point. Yes, if good news and conference call.
Who knows, could be later in the week too. Could they share with potential partners and announce something in combination with the results?
Good post. Czirr is probably just as interested in hammering Adam though this. If they are good let's all RT it to Adam if you have a Twitter account.
It's important that the PR emphasizes the accuracy of the tests show Adam doesn't discount the results if they are positive. Also, he will attack the small study size.
It sounded like TRBA was in an auction, so other companies were bidding also. They may like their mechanism of science and were willing to pay the huge premium for it and then can try and address other organs and indications.
Agree and in theory they can partner if the FX results are positive and if those are share price should rise hopefully and minimize dilution even if they want to continue solo.
These results are very big, allows them to partner for broader fibrosis indications and promote It as a quasi wonder drug. None of those hurts the share price.
I listened, he sounded pretty good, like he expects encouraging results. He mentioned registration with CX trial a couple times.
Good, thanks. Planning to listen to the presentation today, interested in the Q&A portion.
Understood, just referring to Cohort 3 where 3 of the 5 patients improved at least 20% from the baseline, so that's 60% and 40% didn't improve vs. the placebo
If this similar result was realized would it meet the primary endpoint?
Also, what % of the 15 patients does it need to show benefit in?
Agreed, but the stage 3 is getting more competitive if you look at GALT's current presentation. Galt would be smart to quickly partner so they can accelerate trials and potential commercizialtioncommercialization.
Good point. I would think if the FX results are encouraging they could do partnerships for not only Liver but other organ indications. Or would it be enough for MRK, BMY, GSK to buy them for $1b+?
Yes, a huge market. Would this be a treat and cure or ongoing treatment?
The previous cohort 3 showed 3 of 5 patients with 20%+ reduction from baseline. Hopefully they identified patients similar to the 3 who had positive results. With double the treatments hopefully the benefits will increase.
Very good point. But is GILD the only company they could really do combination therapy with? GILD has 3-4 NASH/CX compounds so might be tough. Whereas if it works as a stand alone therapy they could like pursue partnerships with BMY, MRK, GILD and others.
I hope the PR is worded well and if the results are positive they talk about seeking a large partner to facilitate more studies and eventual commercialization.
Thanks, yes. I'm just trying to assess what would be considered fair vs. good vs. great results with the FX trial considering the evaluation tool.
I do agree Adam will discount the results because it is not biopsy based just because he's Adam and he's a tool.
Would reversing this imply a 100% reduction or is there a normal "stiffness" level that is a liver that is ok?
A lot of these bio reports are about wording on the PR and presentation since most drugs affect a % of the patients and have a certain result
If they can determine the attributes of the 3 patients who had success and translate that to the 15 it could be very encouraging and considering more dosages
It was also interesting in one of the presentations they cite GILD's therapies as combination ones, almost suggesting maybe GILD watching closely and would do a partnership if results are good
In looking closely at the Cohort 3 again, it suggests we could see some encouraging news.
3 of 5 patients had reduction in liver stiffness to below 80% of baseline. That is with 4 doses and Phase 2 FX will have 9. 2 patients didn't react. Hopefully they can screen to find comparable patients to the 3 where the drug results were more beneficial.
One question I have from a medical perspective:
What does a reduction in liver stiffness suggest? Is that effectively reversing/reducing fibrosis?
I read this more as an overview of the different methods, not suggesting GALT's is superior.
I think he's done a lot to become a prominent source about NASH overall, and if GALT fails could probably start working at GILD, BMY immediately.
Thanks, well at least we'll see soon
I'm not a medical person, is that basically halting or reversing NASH in those 3? What does it infer?
Did the Cohort 3 using the 8mg show that much or on a trend too given there were fewer doses? I don't recall and would have to go find older presentations.
Is that what you're basing the 20% off of?
If true is that enough to sign a large partnership deal and what would you speculate share price could be with the 20% reduction?
But if the drug shows no efficient compared to the placebo aren't you in theory risking the enrolled patients since there are likely some side effects?
I saw on the Yahoo board that someone claims they were in one of the CNAT trials and their meld went from 13 to 7. Maybe that works.
I think if the FX results are very poor they may cancel the CX trial to preserve cash and see how the Melanoma trial goes. Company could have some value if that goes well.
But yes, it will be sub $1 for sure.
It's $1.70, it's closer to $0 than $5
Hopefully they set the bar such they can achieve it based on their previous Phase I findings
I say this because I think GALT will be a royalty player and not build the whole infrastructure to be a GILD, AMGN, BIIB
Thus, they would maybe be $20-30b if it works in this and other organs, etc.
That is still huge, beyond huge
If good results and gets back above say $8 then could trigger some warrant exercises which would generate several million, maybe enough to get through CX trial
If results are great I would think $20+ is possible
Longer term if this reverses cirrhosis, $5-10b market cap is feasible
That was my thought so these things by the company are not connected since they are operating on the hope it is successful but won't know until they get it presented
Makes sense