It's doubtful that we'll get more trial news this year, with less than a week to go. Next year is an entirely different matter.
To me it's clear that patients in the trial will be reported on, as long as their is news to report. Certainly if hearing is being restored in one, or perhaps a few patients, it will be reported. That's all the news we'll need to make a $2 stock a substantial multiple of that price.
It's hard to say how 2015 might play out. If early news is really great, Novartis could commit to building a facility capable of producing Pivotal, or even Commercial Quality Material. If they do, and once that facility has been approved by the FDA, the initiation of a Registrational Phase II Trial could be possible at any time.
I believe this is the least Novartis must do before the FDA would consider approval, even if many people are walking around in good health with improved hearing. If such a trial were started in late 2015, it may be possible for the FDA to step in and approve the drug in 2016, though it's certainly not the norm.
Personally 2015 could be a challenging year and hopefully fruitful for me as well. In February I should be receiving a stem cell transplant, and much of the remainder of the year will be spent rebuilding my immune system with a donor's stem cells if it's successful. I look forward to that, and GNVC's success.
Happy New Year's,
Gary |
