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Tuesday, October 04, 2016 6:25:32 AM
A clinical hold is not good for any biotechnology company as it could take anywhere from a couple months to a year to resolve. It just depends how bad the situation is, and whether the company can address the problem promptly. The FDA is very difficult to convince to lift a hold once it has been applied. Even if the company is prepared and addresses the problem immediately, it doesn’t mean the FDA will automatically remove the hold. It may decide to still keep the hold until it is satisfied that the problems have been addressed. Therefore if you are investing in a biotech, this is a term you definitely don’t want to see at all. The good news though is that a clinical hold is only enacted in the most dire of circumstances, so it doesn’t happen very often. Just know that anything in the world of biotech is possible!
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