i thought that was the point of aggregating the safety data.
auditing the amarex data would give them the capability of aggregating the safety data.
once that is finalized, hold may be lifted.

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20:33 Scott Kelly: Thanks Antonio. I will address the pausing for Covid19 Brazil trial. In consideration to potentially un-blind the data. The trials in brazil were never put on clinical hold. CytoDyn's clinical team decided to pause the Covid 19 trials in Brazil, as the Data Safety Monitoring Board DSMV, had a scheduled predetermined date to evaluate safety within a few weeks. The DSMB evaluated the safety portion only of the trial, not the efficacy, but the recommendation was to continue the trial with ongoing monitoring, and in term analysis according to the trial protocol. We are currently awaiting to hear from ANVISA. As we wait for approval to proceed with the trial, we will continue to analyze the dynamics of the Covid 19 landscape as it unfolds with a particular emphasis on the critical Covid 19 population. In regard to the potential to un-blinding of the data, we have had many people request the potential to un-blind the data early. We are considering all options and are working with our team, including our own statisticians, our Einstein clinical team in in Brazil, Einstein statisticians as well as our partner BIOMME.

The updates on our clinical programs regarding HIV BLA, there has been some concerns that we are abandoning the BLA for HIV and to be clear, we are not abandoning the HIV BLA. We are currently working to achieve the deliverables required by the FDA to lift the clinical hold. We have requested a type c meeting with the FDA to gain further guidance with respect to completion of the BLA. Once we achieve the lift on clinical hold and receive further clarities from our type c meeting request from the FDA, we will be in better position to provide an updated timeline analysis.

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and before this:

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18:05 Scott Kelly: Thank you Antonio. So, I would like to begin by addressing the partial clinical hold on our HIV program & clinical hold on our Covid 19 program. To provide project management timelines for submitting the necessary materials in September of this year. Our initial time frame of 8-12 weeks, was dependent on us being provided data from former CRO according to industry standards. In the process of analyzing the data, in conjunction with our pharmacovigilance experts, we realized we needed to convert the data into industry standard format. To be clear, We have the data. It is really a data conversion issue. Unforeseen data quality and other data related issues remain a risk that could impact the time line. AM, do you want to add some color on this?

18:50 Antonio Migliarese: Thanks Scott. One of the things we want to highlight is that addressing the clinical hold is our number one priority in the organization and this is an all hands on deck effort. As we mentioned earlier, we have a strong project team in place, which is led internally, by our chief top performers, who have vast industry experience including an internal project manager. This is led by our senior director of clinical operations, Joe Meidling and our vp of project management, Bernie Cunningham. We've additionally engaged in CRO, clinical research organization that has deep experience in root sources in the areas of pharmacovigilance, safety data based management analysis. We also have the regulatory consulting firm that is assisting us with the preparation and review of the various regulatory communication, and lastly we have the data to work with an overall regulatory strategy advising group. This group is one of the most reputable at being regulatory consulting firms led by former FDA regulators.

To provide a little more color on our project management, this team has a line by line detailed project plan with paths, timelines and milestones where its various team members are accountable. Our team holds a series of meetings designed to check in, discuss, progress for milestones, roadblocks and risks to the critical paths. These meetings occurs at various intervals throughout the week and the month. This allows us to identify issues as quickly as possible to trouble shoot and identify ways to overcome and impact on overall timeline. Furthermore, this allows us to identify opportunities to bring in additional resources and where if possible to expedite time.

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