And once submitted, even if reviewed by the FDA, w

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And once submitted, even if reviewed by the FDA, will they all be accepted "as-is" or will revisions be needed? We hope they will be accepted, of course, but to bet that any company would get it all right the first time could be a big ask.

I hope CYDY keeps shareholders and potential shareholders up to date with the FDA process, but I have no idea how/when/if they plan to communicate except for quarterly meetings.

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from 6/30/22 conference call:

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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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IN ADDITION TO ALL THIS, they brought in the External FDA Type Good Clinical Practice Auditing Authority to validate everything being done PRIOR to it being submitted to FDA to ensure that it will be ACCEPTED 1st time.