The Spotlight is now on the FDA (too slow and conservative); breakthrough status soon
Most of us that have followed the science and the Mayo Clinical reports (ASH) believe that the science is real (Nobel Prize) and the remissions are honest. The FDA, not wanting to be too hasty, is taking their time to decide if Imetelstat is worthy of breakthrough status. At some point (soon), they will have to error on the side of the sick and dying and "bless" this drug. Otherwise, they will be remiss in their duties. Let's hope that the FDA is not deaf, dumb and blind. The medicine is safe, the dosage has been determined, and the drug works (CR, PR, CI with potentially cures). Nothing else comes close.
Once FDA breakthrough status is acheived geron wont have to dilute it's shares. THey will be able to sell the drug and cover costs that way!!!!!! Another bump in price as market has probably priced in the dilution.
Someone is getting the "Holy Grail" message today. The potential of a cancer breakthrough of this magnitude has raised a lot of eyebrows (maybe some at the FDA). At least investors are now taking a closer look, and some like what they see. Your thought about the dilution (if it happens) being priced in, is likely correct, and has been holding the stock price back. The realization now is that Geron is in a good financial position for at least a year, and can pick or choose its associates, partners or new owners. Something big could happen any day, considering the success and safety profile of Imetelstat.
On reflection, I have to believe that the FDA puts safety first (do no harm), and that they are aware of the Mayo studies. That means, IMO, that breakthrough status is almost here, pending some new data that will be released to the public in the near future (they probably already have it). I see nothing to stop it, since the current FDA (in historic terms) is moderate to progressive. That is relative, since the FDA have to be careful, and conservative (in the good sense of the word). Helping the sick and needy (in a safe manner) should trump all, IMO.
I agree with astrogen that FDA, accelerated approval, is coming soon. Good medicine and good science will soon defeat market "adjusters" . If that doesn't happen, then the FDA is pretty worthless. There seems to be a reluctance to focus on the short comings of the FDA. Geron and Mayo have it right, and I believe they are bringing the FDA along (BTT).