Hi DD. Problem is that if GZ's "amendment" were to precede MHRA's approval, it would postpone MHRA's approval considerably and would therefore constitute a "Material Event", requiring a PR to NWBO's shareholders.
Since that has not happened, it is obvious that the amendment will be submitted after MHRA's artisan based approval.
" Northwest Biotherapeutics (NWBO) would be obligated to inform its shareholders of an amendment to its Marketing Authorization Application (MAA) if that amendment were material, particularly if it caused a "considerable delay" to the MHRA's decision.
Publicly traded companies are subject to stringent disclosure requirements under market regulations in both the UK (where the MHRA operates, under the oversight of the Financial Conduct Authority (FCA)) and the U.S. (where NWBO is traded on OTCQB). These rules generally mandate the prompt public disclosure of "inside information" or "material" events that could reasonably be expected to influence the company's stock price or an investor's decision.
Materiality Principle: The core principle of securities law is materiality. Information is considered material if there is a substantial likelihood that a reasonable investor would consider it important in making an investment decision. A "considerable delay" in the approval of a core product like DCVax-L for glioblastoma is widely considered a material event for a biotech company, as regulatory approval is a key value driver.
FCA/MAR Requirements (UK): Companies under UK jurisdiction (or with securities traded on UK markets) are subject to the Market Abuse Regulation (MAR). MAR requires issuers to disclose inside information to the public as soon as possible. An issuer may delay disclosure, but only if specific conditions are met (e.g., it is not likely to mislead the public, confidentiality is ensured, and there is a legitimate interest to delay). If a delay occurs, the FCA must be notified immediately after the information is publicly disclosed.
SEC Requirements (U.S.): NWBO, as a U.S. reporting company, must file periodic reports with the SEC, including current reports on Form 8-K for certain significant events and quarterly/annual reports (Form 10-Q/10-K) for ongoing updates. An event causing a considerable delay in a critical regulatory approval would likely be material enough to warrant disclosure in these filings or potentially through a press release to satisfy fair disclosure regulations (Regulation FD).
In practice, news regarding significant regulatory milestones, positive or negative, is communicated to the public via press releases and official filings to ensure all investors have equal access to the information. The company has previously announced the MAA submission itself via a press release, demonstrating its understanding of the need to disclose significant regulatory events.
If a material amendment causing a considerable delay were made without disclosure, the company could face regulatory action from the FCA and/or the SEC, as well as potential shareholder lawsuits for withholding material information.
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