How I see things: Once NWBO reports on the DCVAX-L Phase 3 trial information that was submitted for regulatory review”, this starts a chain reaction regardless of whether the results of the report are breakthrough AA approval or a simple “continue”.
• It allows for disclosure of the Interim Analyses and that the DMC recommendation to the FDA was likely for a halt due to efficacy (ie original reason for submission of data to regulatory agencies)
• Reporting Interim analyses results give the UK Early Access to Medicines Scheme (EAMS) the information they need to give NWBO approval for step 2, which allows DCVAX-L to be sold in UK even though the Phase 3 trial is not finished yet.
• Having Interim analysis, level of efficacy is important for finally setting the price for the DCVAX-L treatment in German and UK, higher relative efficacy vs existing treatment means higher price. (Possibly a formula is agreed on already, price calculation depends on # of months DCVAX-L is better than Temodar SOC)
• Setting price would then enable NWBO to calculate and collect on German Hospital Exemption treatments (sales) already provided for and would allow reporting and forecasting.
• Potential Big Pharma partner for Direct Phase 2 trial may be waiting for DCVAX-L news before signing, who knows. Regardless the AACR abstract was September 16th, reporting great news. Timing is ripe.
• Timing on release of PR's on Phase 2 trials coming up may be strategically optimal, ie approval of trial protocols, # to trials, and which indications/diseases to treat, and timeframe.
• We get to see the army behind Woodford’s $30M investment October 21st and Ondra Partners. They probably brought along a small army of (EU) analysts and investors that are waiting before pulling the trigger. ($150M shelf set up to sell to friendly investors, who have an option for quick profits given the huge short position or squeeze that would occur.)
In the meantime, we’ve been getting info about building up manufacturing, commercialization activities (setting up new trial clinics on the doctor / hospital side and Cognate, Fraunhofer, and Kings College on the mfg capacity side.) This leads to the ability to forecast the timing and amount of achieving peak sales, something buy side analyst can sink their teeth into.
AI
