Chris Recknor11:25: "Re-evaluation of the BLA ti
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Posted On: 05/26/2022 7:06:21 AM
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Chris Recknor11:25: "Re-evaluation of the BLA timelines, we will have a delay in the clinical activities for the BLA while we are performing the pharmaco-vigilance evaluations through the new contracted CRO. Bond was posted with Amarex, and data was obtained for all of our trials, including trial master file, and we will use this to move the BLA forward.
On NASH, we completed Phase 2a for NASH during 2021, and announced preliminary results in January. We are in process of conducting final analysis of the data, and plan to release the updated trial results in the near future. We are real excited about these results of this trial including the MRI findings the pdff and ct1 as well as biomarker data. No approved drug for NASH, and liver disease is the leading cause of death in HIV patients. They are looking for partners."
That was Chris Recknor in the last conference call. Confident.
Scott Kelly is also confident that the Aggregated Safety Data will be solved. Why? Because they feel the audited data from Amarex is good and from which they will move the BLA forward.
That means the data is also good for mTNBC.
drD on YMB also says LL scheduled administration in the mTNBC patients continued following close of trial in November. We will hear in early June, 6-7 from ASCO about this. Hopeful.
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