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Posted On: 09/12/2021 7:06:20 PM
Post# of 148899
Everything said about CROs and assays on the conference call.
I believe on a previous CC it was said that Dr. Recknor got another CRO for BLA.
Quote:
34:44
Let's talk about our cancer program. We have our application for Breakthrough Designation ready to be submitted. The reason it's not submitted is we need to get the sequence. We are changing CROs and we are needing to get those sequences but the application is ready.
1:06:04
We have to get the contract signed to do the certain assays that the FDA has asked us to do and if those are 100% coming to October 15th we'll announce that. But if it's December 15th we'll announce that.
1:07:43
Question: Have we submitted for Breakthrough Therapy Designation for metastatic triple negative breast cancer? If not when are we going to do that?
So I've very frustrated with that also because we have the application ready, everything's set to give to the FDA. But this is cancer patient's lives. We pleaded with our CRO the past one to give us the sequence and they haven't. So we're forced to find a sequence in some other way which is going to delay us and I hope that delay isn't more than a couple of weeks or so.
I believe on a previous CC it was said that Dr. Recknor got another CRO for BLA.
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