Riz: Great find re CYDY reps listed by ESMO to be
Post# of 154590
(Total Views: 2531)
Posted On: 05/04/2025 10:56:18 PM
Riz: Great find re CYDY reps listed by ESMO to be present at the poster board in Munich. As you noted, the reps include Dr Jay, Dr Pestell, and 3 other members of the CYDY Leadership Team. (So the PR title was apparently accurate in referencing the Leadership Team traveling to Munich.) Perhaps of even greater potential significance, the reps also include Dr Hope Rugo, who serves on the Scientific Advisory Committee of both CYDY and Gilead, 3 other breast cancer KOLs from prestigious US Medical Schools, and Daniel Adams, the Managing Director of Creatv Micro Tech, the firm that CYDY used to track patients' circulating tumor cells (CTCs) during the 2020-21 mTNBC clinical trial.
You might recall that a few weeks ago I posted a message speculating that the decrease in CTCs referenced in CYDY's 2021 PR regarding info from the trial might be worthy of acceptance by the FDA as a "surrogate endpoint" predicting efficacy as required under its Accelerated Approval provisions. Although I continue to believe that Dr Jay would be more likely to petition the European Medicines Agency for Conditional Marketing Authorization (its version of accelerated approval) under the EMA's broader enabling provisions, I would note that the EMA could also utilize a decrease in CTCs as a predictive efficacy factor favoring approval. Accordingly, including Mr Adams, the CTC guy, in the CYDY traveling party, reinforces my prior speculation that an announcement regarding accelerated approval from either or both the FDA and the EMA might possibly be in play at ESMO.
Stay tuned. This story seems to get more interesting by the day.
You might recall that a few weeks ago I posted a message speculating that the decrease in CTCs referenced in CYDY's 2021 PR regarding info from the trial might be worthy of acceptance by the FDA as a "surrogate endpoint" predicting efficacy as required under its Accelerated Approval provisions. Although I continue to believe that Dr Jay would be more likely to petition the European Medicines Agency for Conditional Marketing Authorization (its version of accelerated approval) under the EMA's broader enabling provisions, I would note that the EMA could also utilize a decrease in CTCs as a predictive efficacy factor favoring approval. Accordingly, including Mr Adams, the CTC guy, in the CYDY traveling party, reinforces my prior speculation that an announcement regarding accelerated approval from either or both the FDA and the EMA might possibly be in play at ESMO.
Stay tuned. This story seems to get more interesting by the day.
(22)
(0)