Evaluate,
The June payment is the focus of attention right now. I do not anticipate any earth shattering news before that payment is due and neither does the market now. The Direct update should have made some waves but the financial situation and controlled dialogue keeps the lid on tight. Linda will need to pull another rabbit out of the hat and the market apparently anticipates this in the form of a negotiated delay in payment or other more dilutive move. The failure of insiders to solidify a financing trend with another smaller loan last time leaves investors with no other reasonable expectation. Linda is looking at more than 50,000,000 shares at 10-11 cents if debt is not covered any other way. That seems to be the way we are heading so be mentally prepared.
Once we get beyond the next debt payment then perhaps July will give us some answers. I would expect that negotiations with PEI are wrapped up and reimbursement will eventually be done based on a sliding cost/benefit scale already worked out. If positive top line data is shared then the Germans may begin to act independently. At least one patient per qualifying hospital would already have been treated as part of this entire qualification process so reimbursement for at least 9 patients at a predefined rate might be expected when the PEI acts. In and of itself this would have minimal impact but once reimbursement begins in earnest I would expect demand to be high in Germany while waiting for full marketing authorization and this would precipitate a forward P/E valuation. Anticipation of this alone would be a price driver. Britain may have their process for reimbursement in place later this year to early next depending on what various sources have stated.
Direct Phase 2 can begin when funding is in place to get it done. That will require good news and minor dilution coupled with the price increase or another 50,000,000+ shares being sold to get it started while waiting. Very early and regular updates would need to be encorporated into the trial if no supporting news was available from L. For example, measurable immune response at 4 weeks, % stable disease at 8 weeks, necrosis/live tumor load report at 12-16 weeks etc. These types of reports could come very quickly and predictably if encorporated properly into the trial and rapid enrollment for a smaller sized trial ensued. Interest would be expected to be very high and a delay for first in man would not exist so very rapid enrollment would not be difficult to achieve. With injection spacing shortened and multiple tumors injected I would not be surprised to find flu like symptoms happening on a shortened time line than in Phase 1, perhaps within a few days to a week like what might happen with a flu vaccine in some patients who get them each year. Tighter spacing of injections should also speed up tumor necrosis if checkpoint blockades are now being better controlled by continuous DC signalling. I believe NWBO is waiting on near term news before starting Direct Phase 2. Best wishes.
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