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Posted On: 04/13/2022 8:19:31 PM
Post# of 149459
Re: Goosebumps #121928
What Dr Kelly said in the call was that the FDA wants aggregated safety data across all indications and that the new pharmacovigilance CRO has been contracted to work on it. He said that in 8-12 weeks they will go back to the FDA to seek advice on this.
Dr Recknor also said that there will be a delay in the clinical activities for the BLA while performing the pharmacovigilance with the new CRO.
So it seems obvious to me that the 8-12 week timeline is only to make progress on resolving the partial clinical hold for HIV by hopefully assembling the aggregated safety data and then re-engaging the FDA to determine the next step.
I really think the re-submission of the BLA is going to take quite some time. What the timeline is, I don't know, but I definitely don't expect it to happen in the upcoming months.
Dr Recknor also said that there will be a delay in the clinical activities for the BLA while performing the pharmacovigilance with the new CRO.
So it seems obvious to me that the 8-12 week timeline is only to make progress on resolving the partial clinical hold for HIV by hopefully assembling the aggregated safety data and then re-engaging the FDA to determine the next step.
I really think the re-submission of the BLA is going to take quite some time. What the timeline is, I don't know, but I definitely don't expect it to happen in the upcoming months.
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