We can't even say that we will definitely know even by the date of the ASCO presentation on 6/6-7. Why not? Because, it will be presented by Creatv MicroTech, Inc. Although they should discuss the post trial period, I'm sure they will focus on and STRESS that leronlimab resulted in a drop in circulating TACs, (Tumor Associated Cells, Metastasis), in the majority of pts correlating with early therapy response. Therefore, Creatv MicroTech will show that Leronlimab efficacy can be measured using their technology to quantify the drop in CTC, circulating tumor cells or metastasis.

Furthermore, CytoDyn may use Creatv MicroTech's Biomarker test as a means of establishing MOA for the eventual BLA for mTNBC.

If we had kept dosing LL from November 2021 till now or till a few months ago, Creatv MicroTech would have been there as well, on the scene measuring CTCs. Their tests would augment our findings of OS and PFS and testify to LL's effectiveness since their test shows that in the patients who respond to LL, that is, those patients who live, the CTCs go down. When those Biomarkers go up, the patient is no longer responding to LL therapy any more and they subsequently die.

Scott Kelly couldn't have been more clear:

Quote:

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But there’s a very high bar for a breakthrough designation, and we don’t believe that’s enough data. So we will be progressing this molecule forward for mTNBC and looking for more development opportunities.

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