NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

100% agree moreover

If the FDA had flat out denied the new/amended trial design after NWBO submitted it, than that would have been a material event for that would mean DCVAX L could not be approved not matter what the data would say under that new/amended SAP


https://www.orrick.com/en/Insights/2020/05/Managing-and-Maintaining-Clinical-Trial-Disclosure-for-Publicly-Traded-Life-Sciences-Companies

If the FDA has a different interpretation of the data, the FDA’s differing interpretation under many circumstances should be disclosed to investors upfront. Otherwise, disclosure would be required in almost any circumstance to update prior disclosure that would otherwise be materially misleading to an investor. Additionally, it should be noted that companies often obtain negative information from the FDA during the course of drug or device development. This information is not necessarily an indication of approval delay or clinical trial failure, but such information may, under certain circumstances, be material and require disclosure (sometimes very quickly). For instance, companies that become aware of an approval delay or that a product is not likely to be approved by the FDA, must be cautious about disclosing inaccurate or incomplete information (which can sometime force off-cycle disclosure if material enough to the company’s business or prospects