David,
What you say is true. However, don't you think that well over 90% of what's in the UK filing, with changes brought about by questions or discussions with the UK authorities, will be part of the submissions to the three other regulators. I'm suggesting that their applications ought to be well over 90% completed, so things can happen quickly when they're ready.
I don't believe they'll be ready until they either have the EDEN approved, or feel certain it will be before inspections of a commercial production facility are required. I can't be certain of when that will be, but hope it's this year, but if it's next, so be it.
Many people seem to think the company can't go anywhere without a BP partner or substantially more funds. I do believe they'll need some funding, but I'm not sure that they must give away equity, or that it must be a BP.
My belief that CRL will eventually be responsible for manufacturing, storage, and distribution in much of the world utilizing the EDEN brings up the question of, on what terms.
I believe it's the terms that can be structured virtually an infinite number of ways that provides a great deal of flexibility to NWBO. If CRL agreed to terms that gave them some maximum figure for every batch of DCVax-L they made, they would pay NWBO some maximum payment up front to agree to those terms. On the other hand, if CRL agreed to take some minimum amount for each batch, NWBO might pay them for the service, or agree to supply the EDEN's to CRL at no cost to CRL.
I believe their agreement will fall somewhere in the middle, CRL will pay so much for the rights, they'll pay to lease the EDEN Units and for service to the units from the FlaskWorks division of the company. In short, the funding that NWBO will need may entirely, or largely come from CRL. It would also be possible that it's CRL who may at some point take an equity position in NWBO.
I don't believe anything happens before UK approval action, but after that, even if the EDEN approval is known to be awhile, an agreement could be announced with CRL which could provide some funding and support for bringing the EDEN through the approval phase.
I certainly don't know this will happen. I do believe that some trials will be done with products from the BP's, and they may pay NWBO for the rights as well as the DCVax-L they'll be using.
I certainly may be wrong, but I believe that the EDEN can be used to make trial material, even if it's not yet approved for commercial production. Such use would further validate the effectiveness of the unit, as well as DCVax-L.
My point is that NWBO can bring in the needed funds in several ways, and without a BP taking a substantial position in the company. I'm not saying that NWBO may not at some point establish an equity partner with a BP, I just don't believe LP will consider it until the BP is valuing the company somewhere in excess of a $20 billion market cap. That will take more than the UK approval to achieve. Frankly, if data, or the label from the UK goes further than brain cancer, I don't know that LP's ask shouldn't go to $50 to $100 billion market cap for substantial equity in the company. Of course I know nothing about what the UK label may be, but we all know that many cancers have been tried in the UK compassionate use program, the regulators there should have some idea of how effective it's been, even if only in a few patients with various forms of cancer. Could they say, we'll call it tumor agnostic, but demand it be confirmed with additional trials, or Phase 4 data. I believe anything is possible.
Gary
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