You say the MAA grew from about 1M pages to about 1.7M pages, with no explanation given and “obviously none required.”
That raises a basic question: was the page count increase material or not?
If it was material, then why was no explanation required?
If it was immaterial, then what was the point of disclosing it, especially considering NWBO’s sparse history of PRs?
On the expanded label theory, I still do not see how this works. NWBO disclosed the MAA as DCVax-L for glioblastoma. If MHRA merely discusses or refines label wording within GBM, fine. That is normal back and forth.
But if the claim is that MHRA is expanding the label beyond the submitted GBM indication, that is a much bigger claim. I find it hard to believe MHRA would materially broaden the label on its own in a way that affects manufacturing demand, reimbursement, capacity, approval timing, or launch planning without NWBO’s participation or consent.
And if NWBO knew the application path had changed in that material way, then the disclosure question is still on NWBO. MHRA does not disclose material information for NWBO shareholders.
Without disclosure, I seriously doubt the label was expanded beyond the submitted GBM indication.
If there is an FDA example where the agency granted a materially broader label beyond what the applicant requested, it should be easy to identify. You should not have to rely on memory for that.
And even if FDA did that in some case, where is the MHRA precedent? FDA is not MHRA. An unidentified FDA recollection does not show that MHRA is expanding NWBO’s disclosed GBM MAA into a broader oncology label.
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