I’d be looking for an EUA filing pending a successful P2. With an EUA in place and a running P3 simultaneously, I think we could keep things moving.
I thought we’d seen this from a number of other companies over the course of the last year.
But... at this point I’m questioning whether a trial is coming or not. I can’t imagine it wouldn’t be, but we’re well-past Leo’s announced projected start.
Funding Leo’s payroll eats into available cash at a staggering rate, since the company isn’t funded adequately... which could be a possible explanation for the otherwise unexplained cash-raise we got prior to the holidays. Otherwise, what? More sites? More manufacturing?
This was also what CTAP and ACTIV were in place for. To help companies like IPIX move through the hurdles, setup and fund trials etc. Yet we’ve heard nothing about either of these or the company’s involvement with them. Why?
We need an update. This is non-standard communication during a pandemic, with a company advertising having the ‘gold standard of therapeutic treatment’’, while thousands die per day. What is happening?
If B saves lives they can make an exception. The FDA can fast track B right into use. Of course, the data better be great for the 120. There’s also the right to try that comes into play if B becomes a household name after phase 2. We’ll see, let’s see phase 2 start which is late.