Many companies choose to wait until acceptance. Why not wait a couple weeks or so from time of submission to determine if accepted into approval decision process? The SEC clearly look at submission publication (before acceptance) as a negative, because it can be misused to pump price. After years and years of waiting, why would one place the company in the slightest bit of risk by not waiting for acceptance?
NWBO will not PR submission, but will PR acceptance of an MAA or other regulatory applications.
Precisely as they did with PIP, which they submitted in January but we only had knowledge about 6 months later.
Stonkmaster informed about his correspondance regarding that earlier on:
Further correspondence with DI today:
Our engagement(s) with any regulatory body with respect to approvals have not been publicly disclosed for obvious reasons.
We did not speak about the PIP engagement with the MHRA, but we did let everyone know when our protocol for 2 pediatric trials were approved (as an example)
Appreciate your inquiry.
^^
This leads me to believe they will not PR submission, but will PR acceptance of a MAA or other regulatory applications.
I thought through this DI statement further, and while I now think they’ll wait until an MA determination to announce thumbs up/down, I see the multi-definitional word “engagement” more positively. The PIP analogy he chose was also an engagement, and it ended early and successfully.
Fwiw, I thought it was the most carefully worded email from DI that I’ve seen.