Thanks for posting your x-cellent insights so frequently to enlighten us 😶
Your incessant reposts about Specials are myopic—compassionate use serves a different purpose & has distinct value from commercialization after marketing approval. It’s not about revenue, just as clinical trials aren’t conducted to generate revenue immediately. NWBO has GAINED invaluable real-world data supporting both safety and efficacy, supplementing their clinical trial data. Specials data also supports proof-of-concept evidence validating dendritic cell platforms in general as a key component of cancer immunotherapy.
Compassionate use programs can significantly expand research & discovery. Specials can provide insights comparable to those from clinical trials and may inform the design of subsequent clinical studies too!
The greatest value of the compassionate use program extends well beyond any revenue at the pre-commercial stage and we have the management to thank for running a successful program. The Specials Program fits beautifully into the big-picture strategy to achieve broader commercialization…
The same MHRA regulators who have been supporting the long-running and ongoing UK Specials Program may also consider its data as part of their review if those data are included in a regulatory filing package.
Regulators may also choose to consider any analyses that are published in the independently peer-reviewed medical literature, and it’s worth mentioning that the MHRA has already awarded several approvals, including their approval of the MIA (a prerequisite of the MAA).
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