Other Catalysts to Follow Interim Review:
There are other catalysts possibly coming soon beyond results for Direct and the interim review, but they may be gated by that interim review.
There is also the application for the European compassionate care status that they have been working on for some time. A response is due. I don't remember where in Europe that status was to apply, but even if it was just one country it would be a big deal, as far as I know. Further, the hospitals being setup for the L trials in Germany applied for reimbursement for the clinical costs. If granted, the $5M/50% funding already offered by the Germans for their clinicals doubles, as far as I know. My guess is that those two decisions will not be made untill the interim review is completed, but will be made soon thereafter. I believe that if either of those decisions go NWBIO's way, it/they will be significant catalysts.
Further, they are apparently going to open another mfg facility somewhere soon. Most think it will be in Europe somewhere. To me, Germany would make a lot of sense. That would also be significant news.
But I'm not counting on results for Direct any time soon. In the recent Oppenheimer conference, the CEO said maybe 1 or 2 case statuses in Q1. That's through March. She said they are having to spend more time in phase 1, where dosing and intervals are played with for best results and least side effects.
What I gather from the blogs is that Direct is an order of magnitude more valuable than L. Hard to imagine, because L is so valuable. But at the same time, if it is that valuable, I don't care if they take an extra quarter to get it to phase 2. In fact, I hope that financing and other pressures allow them the luxury of fine tuning the dosing, interval, and anything else they are allowed to alter such as modifications to whatever the chemistries are that accompany the dendritic cells, as well as details of the dendritic cell prep. Anything they can tweak they should be tweaking until they are absolutely satisfied that they have optimized it. That is what I would want them to do, and I am heavily invested.
In front of Direct is a huge amount of wood to chop, and I think it is wise of them to spend whatever time is needed to sharpen their axe. We know that the FDA can and does sometimes approve on phase II results, and if Direct works anywhere near as well as hoped, then it would definitely be one of those candidates, at least for inoperable tumors. They also have the option of doing a Phase II in Japan where the likelihood of approval on phase II is even higher.
Further, they do need more funding to finish L. You can only raise excitement with old news so many times. I am sure they would much prefer real news. Big, real news is hard to come by, and they can't afford to waste it. They stand to benefit far more from big news on Direct much later this year when they need funding.
Thus spending more time in phase 1 perfecting Direct is a two-fer. I have a hard time passing up two-fer's and the management at NWBIO probably can't afford to pass up a two-fer.
I think your market cap estimates are reasonable, but I always use the true number of shares including warrants, etc., which was 61M recently. My understanding is that 61M is still a very small number of shares for a company with such a pipeline... rather, the implied market cap of $256M for the current share price of $4.19 is still very small given the upside and likelihood of success.
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