I don't believe that anyone can prove we've lost even a day toward filing the BLA, that's what's required to get approval. Approval has nothing to do with when TLD is announced, or when the data is presented for peer review in an form, it's all about what the regulators do.
No one here is certain of whether NWBO is working with the regulators directly, in some form of expedited approval, or not. I don't believe all four regulators work together, so no telling what they're doing with each of them. Many here are concentrated on expedited path toward approval by the FDA, what about the other three regulators. I suspect we're taking the quickest path possible with each of them.
I don't think I'm any different than most here, I'd like to see TLD ASAP, but I cannot say the company is sacrificing anything long term by taking the path they've selected, and I'm willing to not complain about them doing it their way. Right now I still believe an approval is not out of the question from one or more of the regulators this year, though it's far more likely in the first half of next.
I believe that much will happen before the first approval, certainly we could have a partnership, possibly we could be bought out. I would practically bet that any company that's interested at this point has probably filed a confidentiality agreement with the company, and currently they have full access to all the data, and they may have had it even before the company did. I cannot say how many companies, but after TLD is out, others may add themselves to those interested. Nothing would be better than a bidding war to see who partners, or buys the company. While I hope it's a partnership, I don't believe anyone would believe they failed if it's a buyout.
Gary
