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Re: PennyWorld post# 32783

Monday, 01/30/2023 7:46:49 PM

Monday, January 30, 2023 7:46:49 PM

Post# of 34618
The company has referred to the AML trial as a pivotal PII in in their presentations. I don't have links to those as the ones on the website are only archived for a certain period of time. The fact that they are referring to their PII as pivotal is the confirmation that they are trying to avoid the PIII as that is what a pivotal PII will accomplish.

Now I get to backtrack some comments. Yay. While the company is stating that the trial is pivotal technically in their 10K filings they are saying "potentially" pivotal. I didn't find this until right now when I was looking for a link to send you. It is
in a section that I don;t normally read when these filings come out. HERE is the 10k and here is the excerpt from that 10k in question. "We are conducting a Phase 2 clinical trial in post-allogeneic HSCT patients with AML in both the adjuvant and active disease setting under our IND, and this trial may become pivotal pending the results of the interim analysis." So in filings they are being technically correct in their wording and in speaking they are taking some liberties they probably shouldn't be. Add this to the list of knocks on management.

So, I guess now we need to await official confirmation that the trial is indeed pivotal. If it is, then they will get to skip the PIII so long as the results are good. If not, a PIII might be in the future I apologize as it sure seems my past comments on this topic were unintentionally misleading.

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