NDAs are not a material event. Having a clinical h
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Posted On: 08/16/2022 8:29:11 PM
NDAs are not a material event. Having a clinical hold lifted so that you can proceed with clinical trials is something that might affect someone’s opinion of whether to invest or not, so IT IS A MATERIAL EVENT.
Enough with the NDA stuff. The question was: can the company withhold the information that the FDA lifted a clinical hold, given that the hold prevents the company from continuing to develop its business. NO, they cannot withhold that information.
If that’s not a material event, what would be?
Enough with the NDA stuff. The question was: can the company withhold the information that the FDA lifted a clinical hold, given that the hold prevents the company from continuing to develop its business. NO, they cannot withhold that information.
If that’s not a material event, what would be?
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