RE:The Bracelet-1 90 day exclusivity should be over x Feb 2023During the August 12, 2022 Webinar at a timemark of 06:55 Matt Coffey gave an August 12, 2022 Bracelet-1 completion date which differs from PrECOG's June 24, 2022 announced final patient enrollement. The additional 7 weeks should have been more than enough time to evaluate the data since it was being monitored and evaluated on a real-time basis.
If ONCY is setting August 12, 2022 as the official date for the completion of enrollment in the Bracelet-1 clinical trial - then adding in 16 weeks for the data assessment the timeline is extended to December 09, 2022 which should have been time eough to also clean the data and deliver a report to Merck KGaA/Pfizer on the 48 patient trial since PrECOG had already announced that the final patient was enrolled on June 24, 2022 and ONCY was monitoring and reviewing the data on a real-time basis.
Consequently from the above Merck KGaA/Pfizer's 90 day exclusivity period would start on or around December 09, 2022 and extend to March 03, 2023 at the very latest.
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August 12, 2022 ONCY webinar - Matt Coffey statements:
6:55
And now I’d like to turn our attention to an important announcement we made in our press release that was distributed early this morning. This was the completion of enrollment Bracelet-1. A randomized phase two trial in HR positive, NER2 negative metastatic breast cancer. With Bracelet-1 enrollment finishing near the end of last quarter, the trial is now less than four months away from a complete daily set on its primary end point of week 16 overall response rate. Once we've cleaned and lock the database, we will provide our partners at Pfizer and Merck Serono with a report that will trigger the start of their 90 day period of exclusivity during, which the data could not be publicly announced.
As we are already monitoring the data from this open label study in real time, we're able to review the data as it develops, which allows us to engage investigators, cooperative groups and regulatory consultants on a confidential basis.
7:46
While a brief delay in Bracelet-1 enrollment combined with the 90 day exclusivity period from our contractual obligations to Pfizer and Merck Serono, and scheduling a major medical meeting, we have pushed anticipated disclosure from the end of 2022 into Q2 2023.
8:02
It's important to realize that this does not impede our lead program’s momentum. We intend to take advantage of this 90 day quiet period to engage with regulators on a confidential basis during this time to discuss the optimal design of the future registrational study. This new study will be informed and supported by Bracelet-1’s results as well as by Pela’s robust safety database, Phase I efficacy data demonstrating its single agent activity and the afore mentioned results of 9213, which notably counts as one of the two pivotal trials required for approval by the FDA.