fox7mf wrote:I think most would agree with much of what you assert Ksw...except, there are those who believe PFE have been in possession of final Bracelet data for quite sometime, and may, in fact, be nearing the end of their exclusivity/right of first refusal. Of course, this is a moot pt regarding a Roche offer...they'll do so regardless, and I imagine within 60 days.


Hey fox7mf,

Was away for the weeked just with my phone. But just back at my computer this morning now and went looking for data from an old conference call with respect to what Matt has stated in the past.

Found it. Thought I would share. In the 2022-08-12 ONC Webinar, at 6:55 into it
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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.
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Based on the above statements, it sounded to me like the data set was not locked yet, so the final report has not been written yet. ONC stated BRACELET-1 final data was less than 4 months away from its primary end point. So less than 4 months, so lets say 3.5 months from 2022-08-12 would be mid Nov 2022 for the 16 week overall response rate fi al data. Which is basically now. And I assume the primary end point data is to be added into the final end report to be issued to Pfizer.

In this statement...
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
ONC states once the data base in cleaned and lock they will write the report.

Based on this, was the reason I have assumed that the BRACELET-1 final report has not been issued to Pfizer yet. 

If BRACELET-1 final data wrapped up mid Nov 2022, then I assume there is a period of review/cleaning and locking the data, then some time required to finalize a written report and issue it to Pfizer.

Maybe 2-3-4 weeks to do all of that. Maybe longer I have no idea.  Maybe they can clean and lock and issue that data almost immediatelty ?????

But in any case, based on the above, I was assuming Pfizer would not see the BRACELET-1 final report with end point data until at least Dec 2022, starting their 90 exclusivity period.

Yes, Pfizer would have real time data, but IMHO not a final report report that would actually and contractually start the date of the 90 day period.

Now whether or not this statement...
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. 
means ONC can get the data to Pfizer earlier and satisfy the ONC/Pfizer contractual agreement to start the 90 days, I have no idea. But it sounded to me like a complete final data report could not be written until after the 16 week overall response date was reached, so that data could be included. Which is only about now.

If Pfizer is issued the final data report in Dec 2022 or early 2023, a 90 day exclusivity period where data could not be publicly released would take ONC out to Q2 2023 for full disclosure as noted in the following...
combined with the 90 day exclusivity period from our contractual obligations to Pfizer and Merck Serono...

we have pushed anticipated disclosure from the end of 2022 into Q2 2023.

and all the ONC mentioned timing dates would tend to seem to align with that schedule.


Anyways, not trying to be argumentative, and it would be better for all of us if I was incorrect on this.

But based on the above, was the reason for my assumptions that Pfizer has not yet been issued the final data report.

Which as per my previous post, buys Roche a bit more time if they require more time to make any decissions.

But I still expect to see Roche step up before Pfizer gets to the end of their 90 day period.

Just my thoughts.