I think it is impossible to guess in any meaningful way, given that we have barely any facts to go on as to where CYDY is in the whole process with the FDA, but if pressed to guess, I would say no, the hold will not be lifted by the end of the year. Before anyone gets all upset, hear me out and let me know if you think something is wrong with this logic.
CYDY says it submitted "a first series of documents" to the FDA in September. That is very vague as to how many series of documents must be submitted and how much longer they think they will take to be submitted. Then, one has to factor in that this is just one of many things the FDA is working on, so how long does it take for review of each series of documents? A week? 90 days? We have no idea, as far as I know, but again the first series was submitted a month ago and to the best of our knowledge, we have heard nothing from the FDA as of yet.
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.
CYDY says it submitted "a first series of documents" to the FDA in September. That is very vague as to how many series of documents must be submitted and how much longer they think they will take to be submitted. Then, one has to factor in that this is just one of many things the FDA is working on, so how long does it take for review of each series of documents? A week? 90 days? We have no idea, as far as I know, but again the first series was submitted a month ago and to the best of our knowledge, we have heard nothing from the FDA as of yet.
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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