First, thank you to all the people (dennisdave, antihama, doc_logic, AEK, etc.) who have been reading the tea leaves with respect to hiring (or lack of hiring) at NWBO in recent months and speculating on what this may mean with respect to the company's strategy following its first regulatory approval.
I agree with those who have said that the apparent lack of hiring at NWBO points to the conclusion that the company will not try to sell and distribute DCVax-L as an independent company, and therefore has some sort of partnership or alliance in mind. Also agree that this partnership may already be in place, or partly in place, and NWBO is merely following steps outlined in a memorandum of understanding that has not yet been made public. I believe it was Poor Man who said such an agreement would include a "term sheet," and that NWBO may be busy fulfilling those terms in anticipation of a future transaction to be announced at a later date.
Due to LP and Les' legal backgrounds, and the company's heavy investments to date in securing patents and intellectual property protections, (thanks to ATLnsider, Henry_Muney Hoffmann, Lykiri and others for keeping us abreast of these!) I find myself agreeing with those who, in a recent Twitter poll, are predicting a major licensing deal with a Big Pharma partner (such as Merck), shortly after MHRA approval, as opposed to an outright sale of the entire company. In this case, I think the revenues accruing to the company in future quarters would be in the form of royalties, as opposed to sales from prescriptions. I am invested in another biotech company (Halozyme Therapeutics) which obtains much of its revenues from royalties that Big Pharma customers including Roche, JnJ, and BMS, pay Halo to use its IP on a recombinant version of a human enzyme (hyaluronidase), to facilitate subcutaneous injection of large molecules such as monoclonal antibodies. It's a perfectly viable business model and as I said earlier, licensing aligns well with Linda's background. (Her training is in law, as opposed to medicine, and to my mind this helps explain the unusual way the company is being managed.)
With respect to the combo trial (adjuvant ATL-DC + PD-1 mAb) and its incredibly promising (though early) results, I am wondering if NWBO may choose to pursue a slightly different indication from the FDA than it seeks from the MHRA? For example, it could be possible for NWBO to pursue a single-agent indication from MHRA for use in patients with newly diagnosed glioblastoma, and then to apply to the FDA (and perhaps other jurisdictions around the world via Project Orbis) for an indication to use the combination in relapsed/recurrent patients.
On further reflection . . . . if I were LP, running a company that is under heavy financial pressure from lenders and shareholders, I might favor taking the path of least resistance first, just to get some runs on the scoreboard so to speak. So perhaps the first indication sought from the MHRA would be for use of DCVax-L as a single agent in relapsed/recurrent GBM, which is the lowest-hanging fruit. I'm guessing it would also be pretty easy to persuade NICE to reimburse for these patients, and this might heighten the appeal to Big Pharma for a licensing deal.
I confess I haven't fully wrapped my mind around how things would work at the Advent-run production facility in Sawston in the event that NWBO licensed its IP to a BP. We know (or think we know) that LP and her husband own a controlling interest in Advent, and that NWBO has been paying Advent for its services at least partly with shares of NWBO stock, so what's good for NWBO is also good for Advent, and what's good for Advent is also good for LP. (This is complicated!)
So . . . . if NWBO licensed its IP for use by Merck (for example), and then Merck sold 10,000 doses of DCVax-L, and placed an order with Advent to produce those doses over a period of months, then that seems like it would be a win all around: sales revenue to Merck, royalties to NWBO, and contract manufacturing revenues for Advent.
However, if I were Merck, I might want to steer clear of such a deal, because it would force me to pay whatever Advent wishes to charge to make my drug. If I were Merck, I'd want the freedom to go find another contract manufacturer (perhaps CRL?) or perhaps to even make the drug in-house according to the recipe I bought from NWBO, and produce it cheaper than whatever Advent was going to charge me.
Just some thoughts and musings while on the commuter train to Philadelphia. I'm sure some of these musings betray my ignorance of how patents work, and of the intricacies of contract manufacturing of pharmaceuticals, and for those gaps I apologize in advance.
Good luck to all.
-- OJ
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