I am long sesn so I want to hear good news Monday, but I am trying to think of scenarios where the news is not so good and am having a hard time. If there was something wrong, or the FDA needed clarification on something, I would think the company would work on that prior to having a CC, not with only one business day in between. They did announce results of the meeting would be presented within 30 days, so if something needed fixing, I would think they would take as much time as possible to work on a solution so that could be also presented at a CC. Other reasons I am optimistic:
- Yesterday was the 6th Type B meeting company has had with FDA. They have been working closely with FDA over this time and designed their trials to maximize probability of approval. Oncology products that make it through BLA submission have an 82% chance of approval.
- FDA approval is based on favorable risk / benefit assessment. Responders with Vicinium are 15 time more likely than non-responders to remain cystecomy-free at 2.5 years. This is a huge quality of life issue for a terrible disease. Competition Valstar was approved in the 90's and hurts healthy cells as well as cancer cells. Vicinium only kills cancer cells.
- BCG is in short supply shortages are expected to continue at least through 2019.
- Safety profile is excellent and FDA has already granted fast-track designation.
- No further clinical studies required.
- Satisfactory meeting with FDA on production on May 21.
- Institutions own almost half the company (not a driver for FDA approval, but they clearly see something they like).
I have been burned before but to me, this sounds like a positive Monday am.
