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Re: gr8db8 post# 1281

Friday, 09/22/2017 3:24:45 PM

Friday, September 22, 2017 3:24:45 PM

Post# of 2099
We know that the patients that enrolled in the VB-11 arm were in worse share than those enrolled in the control arm, both in the rGBM and Ovarian p2 trials. For rGBM this was made explicit in LifeSci OSCO report. I heard Dr. Harats make this claim for Ovarian in a presentation he gave in Hebrew.

Moreover, we also know that FDA granted VB-111 for rGBM a special status (orphan and/or fast track?) whereby if the P3 trials succeed, then the company will be quickly/automatically approved to market VB-111.


gr8db8 wrote:
The failure of VB-201 in psoriasis and ulcerative colitis in phase 2 is now a positive factor for the company, imo. It shows that if a treatment is not working, the company will stop it early. This can be grouped in the positive factors bucket (like facilities, Thai Lee, upcoming OVAL study, etc). They are positive signs that the company is doing the right things but they don't impact the phase 3 GLOBE results.
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