NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

If they are not unblinded yet than they have not been exposed to trial results. In that case the mandate to disclose negative trial results is a bit different but its not that simple.

Its too bad no one read my post here because my post here is quite interesting https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167260618

1. First of all.
NWBO made certain statements in their 8K's that would be misleading if they had no unblinded
A duty to disclose a non-public material fact may arise if the company makes statements that will mislead unless the company also reveals the negative test results. Joseph W. Cormier Mahnu V. Davar Volume 29 2013
https://scholarship.law.edu/cgi/viewcontent.cgi?article=1016&context=jchlp

Now NWBO repeatedly said this in their previous 10Q’s:

These processes included data validation, analyses of the data by independent statisticians, preparations by the statisticians of summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and independent experts, in preparation for publication in a scientific journal and public announcement. This series of processes is under way

If they by are NOT be unblinded and have NOT started submitting a scientific publication (for which one must be unblinded right) then that repeated statement in their K and Q is misleading. Now before anyone claims safe harbor let me quote this:

Additionally, the safe harbor provides that only companies and executives that meet a high level of culpability will be liable for predictions. This requires plaintiffs to plead and prove actual knowledge that the forward-looking statement was false or misleading.80 On the other hand, many courts have held that some form of extreme recklessness will satisfy the scienter element of a § 10(b) claim 81.
80. 15 U.S.C. § 77z-2(c)(1)(B) (If the statement is made by a natural person, a plaintiff must prove that that individual had actual knowledge that the statement was false or misleading; if made by a business entity, a plaintiff must prove that it was made with the approval of an executive officer who had actual knowledge that the statement was false or misleading.).
81. William 0. Fisher, Key Disclosure Issues for Life Sciences Companies: FDA Product Approval, Clinical Test Results, and Government Inspections, 8 MICH. TELECOMM. & TECH. L. REv. 115, 120 (2002)

In other words. A listed company cannot just (keep) saying whatever they like under safe harbor or any other amendment and claim it was just forward looking. If NWBO is by now not unblinded then they have mislead its investors.

2. Second. Thank your for quoting LP on this.

Is there ongoing dialog with the FDA regarding formation of the SAP and will you wait to unblind until after the SAP is approved?
Answer (LP): “Definitely ‘yes’ we won’t unblind until the Statistical Analysis Plan has been approved by all regulators

Now let me quote

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

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

Regardless, if NWBO is theoretically unblinded or not or what they said on the subject. Omitting an event such as the FDA not agreeing on the submitted amended SAP would have been in conflict with SEC Rule 10b-5 of the Exchange Act, 17 C.F.R. § 240.10b-5 (2007). The FDA dismissing the amended SAP should have been disclosed in a 10Q or 10K by NWBO. Moreover if you go over FDA regs on the amending of SAPs, its not such of a big deal. They only requirement is that the biotech staff at the time of amending the SAP is objective.