With today's Phase 2 announcement it seems like a good time to make a special guest appearance on this board.
With the singular exception of the way the Cohort 2 results were released the GALT management team has done an outstanding job of bringing GR-MD-02 to the start of Phase 2.
The Phase 2 trial(s) are going to focus on changes in portal hypertension (with the blessing of the FDA) as the endpoint. That is very significant since their successful animal trials (which reversed fibrosis) were based in large part on the same end point.
It doesn't matter what amateurs like Feuerstein believe regarding liver biopsies or anything else, the FDA is the final judge on any trial and having them on board with this design is absolutely critical to eventual approval.
When you look back on the development of this drug it is clear that Traber and his team knew exactly what they were doing at the beginning of the pre-clinical trials and they have enough money to complete all this with no further dilution.
As for the lawsuits (if they ever develop), they are based on GALT misleading the public and it's entirely possible that the Phase 2-FX shorter trial is targeted in part to end this.
If you also look at the Cohort 3 results, the changes in both Fibrotest and Alpha-2 macroglobulin after the 4th dose and 14 days are almost stunning in the way they improved-Phase 2 has 26 doses and you would have to think that the longer this is in the system the more it will help both slow down and possibly reverse advanced fibrosis.
I am of the very strong belief that GR-MD-02 will eventually be approved since the bar for approval (slow down the development of Fibrosis) is so low; they don't have to show reversal, just extending life a few years would be reason enough to approve the drug since there is no other treatment.
I hold more shares now than I did in mid-2014, the only change I made was to sell off GALTW and replace them with GALT common shares to account for the longer time period before potential approval, which will probably go past the expiration of the warrants.
I have no explanation for why the share price continues to hover between $3 and $4 and, while it is frustrating, it doesn't matter in the long run, at least to me.
