Antihama,
I certainly don't know, but I believe the company should be very near to completing their BLA. If I'm correct, by this time I believe they should also have CRL, or someone else, working on preparing for inspections from the regulators they'll be making the vaccine for. While I believe it's CRL who'll be the one, it's not impossible that under confidentiality a partnership that will be triggered by some future event has a partner who'll provide the facility for making the vaccine to serve the market in many countries. If such an arrangement were in place, a BP partner might well make the investment up front to build the needed production facility at no cost to NWBO. On announcement of the partnership all of this information could be revealed.
I'm frankly uncertain if the triggering device to a partnership may be reaching a specific stock price, or a milestone event, which could be as early as TLD to as late as post BLA submission. Clearly if the partner is making the product, inspections would be required with the filing of the BLA or before. I don't know that the FDA won't do this in complete silence if that's what the involved parties request.
The FDA has to disclose that it's being lied about. If a company doesn't believe it's required to announce something they're doing with the FDA, the FDA won't say it's happening unless it's required in their public filings. My point is that investors rarely hear about exchanges between the company and the regulators.
If NWBO had a partner, and if the partner were paying them for achieving certain milestones, than those milestones would be material events, and shareholders need to be notified of material events. Without such payments, it's up to the company what they consider material, as important as filing a BLA is, if they don't deem it to be material, they can avoid issuing a PR if they so choose.
I've been invested in IMGN for decades, I don't think I've yet heard of a trial they initiated announced by them before an investor found it on Clinical Trials. I've often wondered if it would ever be announced if no one found the public filing. In almost every case, updates to clinical trials has been found prior to a company announcement, if it wasn't completely ignored. My point is that the secrecy they seem to operate with is similar to how NWBO is operating. The FDA and other agencies do their jobs, if something belongs in the public domain, it will be put there, but it won't announce them. Investors frequently find filings days, weeks, or even months after they've been put in the public domain, it's a matter of how hard people are looking. I for one occasionally check clinical trials to see if an update has been made, I seriously doubt the company will announce it.
Gary
AI
