You are correct, that they have the data, but that the data was not properly formatted. Regardless, to the FDA, they don't have the data because it wasn't given to them in the format they are prepared to digest. Therefore, from the perspective of the FDA, they don't have the data and therefore, the product is not safe.

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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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