RE:RE:PP not close yet.If there was a big pharma that finally decided to step in for jv discussions, that would produce similar delays. We'll see if this can be that.
It's a possibility, given:
- that we're 45% into a pivotal NMIBC ph. 2
- that Breakthrough application will be possible by mid-December
- that we already qualify (and even surpass) surrogate points required by the Accelerated Approval program
- that despite the fact that our first 12 patients have been undertreated, we still have superior results
- that the FDA is advanced in its talks with the Congress to give access late-stage Accelerated Approval treatment to early stage patients (FrontRunner project)
- that the FDA Orbis program allows concurrent submission and review of oncology products among 7 international partners (US, Canada, UK, Australia, Brazil, Switzerland, Israel, Singapore)
- that the credibility of the Special Pathogens, National Microbiology Laboratory, Health Canada is well established, so their desire to have our preclinical tests completed against COVID-19 speaks bold on the potential and chances of success
- the trending and reneweed interest in vaccines by big pharmas (this week's WSJ report)
- that we're about to launch NSCLC and GBM trials
So if there was ongoing jv discussions, you wouldn't be informed as these are private, informal and NDA discussions, given all that's at stake. Once an offer would be officially presented, we would be informed though via a news release.
We'll see. But it's more than a possibility. given all the above.