NorthWest Biotherapeutics Inc (NWBO)

[akblack]

Just to play Devil's Advocate for a moment, "what if" they are not unblinded yet?

If not unblinded, then the 4-day clock hasn't started ticking yet. The only reason I bring this to light is that, I believe it was ASM 2018, LP directly stated that they would NOT unblind until all 4 RA's have approved the SAP. To my understanding (correct me if I'm wrong here, the US RA hasn't yet updated the clinical trials site publicly aknowledging that they've accepted the SAP (do I say that correctly?)

That being said, I do hope they "are" unblinded by now and the click is long since timed out to keep your position true, however, there is no guarentee for any of us that the clock has even begun to tick (only hypotheses and hopes supported by "evidence" that supports our beliefs and desires for it to be the case.) Happy to hear arguments to the contrary, in case I've missed something here ...



Supporting Info & Link:

"NWBio said that they would not unblind the data & let the statisticians start the process of reviewing & analyzing the data until they got buy-in on the SAP from all 4 RAs; in which here is a direct quote from the 2018 Annual Shareholders Meeting which took place on 2/2/20219 at 1:30 EST:

Question #10: 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. FDA and other, four regulators. We intend publicly as a company policy, which is pretty standard for companies, we don’t talk about our communications that are ongoing with FDA or other regulators. We only say results, so I can’t comment on interim communication type things, but in case there is any [lack of] clarity about remarks earlier about the SAP, it is an actual submission to the regulators. Like when you apply for an IND, that’s Initial New Drug, application to get a clinical trial approved or when you apply to get a new product approved. You make an actual submission to get your SAP reviewed and approved.”

Here is also a direct quote on this subject from their June 2019 press release:

As soon as the SAP is finished (including review by advisers), it will be submitted to the regulatory agencies for each of the 4 countries where the trial was conducted, for their comment and buy-in. As soon as the SAP process is completed with the 4 regulatory agencies, and the simultaneous data checking is finished, the trial will be unblinded and the data analysis stage will take place and result in top line data. "

Source: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167261462



Additionally, "Here is also a direct quote on this subject from their June 2019 press release:

As soon as the SAP is finished (including review by advisers), it will be submitted to the regulatory agencies for each of the 4 countries where the trial was conducted, for their comment and buy-in. As soon as the SAP process is completed with the 4 regulatory agencies, and the simultaneous data checking is finished, the trial will be unblinded and the data analysis stage will take place and result in top line data."

Source: https://knowwhatyouhold.com/t/pseudo-progression-trial-design-regulatory-buy-in-evidence/21