Cyrus said on March 15 they had responded to the F
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Posted On: 04/05/2023 12:25:45 PM
Cyrus said on March 15 they had responded to the FDA request for additional information. The FDA has 30 days to respond and the cc on Tues falls within the 30-day window. Lifting the hold is a big deal, and I would expect it to be announced during a CC along with other updates.
He does not need to announce a request for additional information given he didn't PR their last request/delay from the FDA. They have 30 days to respond, so saying they haven't decided probably isn't the purpose of the call.
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But, is the hold being lifted?
Of course not because otherwise Cyrus would have announced our CC in a different way…like…”FDA lifts the clinical hold and our company update is scheduled…”….something like that…
He does not need to announce a request for additional information given he didn't PR their last request/delay from the FDA. They have 30 days to respond, so saying they haven't decided probably isn't the purpose of the call.
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So, next week he will tell us that the FDA will not lift the hold anymore or that the FDA hasn’t decided yet…
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My comments are just my opinions and should NOT be taken as investment advice.