You should look at the Gov. Clinical trials page and you will learn that this is a P2 trial, not P1 as you were incorrectly saying. The Mayo Clinic trials are primarily focused on efficacy, not safety. GERN has already completed about 10 phase I Clinical trials (with something close to 400 patients) that have received Imetelstat without unmanageable side effects and Imetelstat is know to be tolerable.
You should read and study the spectacular results of the MF trials, as reported by Teferri and Scarlett,.You also should study the FDAs new rules this year for "Break through therapy" which I am sure will surprise you. In brief, the FDA has started granting applications for Drugs obtaining the results that Imetelstat has already achieved BEFORE all the usual testing is completed!
In one case that I have posted, the FDA allowed a single arm test with 111 patients to form the basis of a break through drug designation. Tefferi already has more than 50 patients enrolled in a series of coharts and closely related applications, MF, AML and MDS.
You somply don't appreciate how close GERN may be to getting FDA approval.
When you have a verified break through, FOR EXAMPLE with rarely or never before attained CRs and PRs, and it saves lives, the FDA will let you sell the drug if it satisfies their list of criteria. It is quite clear to me that so far Imetelstat in MF will qualify for the break through therapy designation. Scarlett has not started talking about this, but he will!.
It appears almost beyond question that Imestat appears to be better for most MF patients than any other drugs avalable and with acceptable side effects that are worth the benefits. You should not accuse people that are enthusiac about the drug benefits as being "mindless."
We have at least one board member that knows from personal experience that this is a wonder drug so far for her husband, and all the commentators agree it will be a "blockbuster" drug if these preliminary results hold up.
I love war! anyhow ref. ur comments of break through therapy, orphan status= blah blah blah. you know nothing of bios, esp small cap bios.
give you one quick example of that's. ttnp received orphan staus, break through therapy from fda. look what happen. fda gave a crl after fda panel voted yes.
Oh yes I have made $$ shorting gern already. I will buy gern if it goes lower for that news of (orphan status) the sell it after the run up.
everyone thought dndn, arna,vvus amrn, aria was blockbuster too.
What im saying gern is far from market and if it ever gets there.
Im here to make money