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.