I have a friend who is a Gastroenterologist at a major U.S. hospital and asked him to review the Phase 1 Cohort 1 findings.
He isn't a liver specialist and doesn't know anything about GALT or the drug other than what is in the presentation but thought the results were very encouraging but also very early.
The most important thing to him was the absence of SAE's in the patients across the board, that is obviously a huge stumbling block for most new drugs.
He said, 'It will be interesting to see how the second group of patients, on a higher dose, respond. The main difficulty in this study is the lack of an easy marker to follow; the ones that are used are quite recent, without a strong track record; the biopsies remain the gold standard, then the elastography.'
I know the stock is down this week in reaction to the news but it is still up 50% from January 1st, 600% from January, 2013 and GALTW is up 1400% since January, 2013.
As I am a long term holder this week's events are the best news I've had in 5 years as the first human results track the animal results-GALT will clearly move to a Phase 2 trial and, with the Fast Track designation and no SAE's, it most likely wouldn't take much for the FDA to approve the drug for at least treatment of advanced liver disease, a market that has no cure other than a transplant.
Even if GR-MD-02 only extends life for those patients by several years without the need for a transplant (which is very, very risky) it provides a significant improvement for people with that disease and, as Tesla1 says, how long will the FDA want to wait before approving this drug when people are dying every day from liver failure?
