That question may be what's the safety data from the phase 3 trial although safety was established in phase 2. There is very little chance they finished the clinical section of the BLA in under a month so the partial hold may be lifted after submission.

Here's the FDA's definition of a partial hold, keep in mind the IND is only for HIV -

Quote:

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Partial Clinical Hold: A delay or suspension of only part of the clinical work requested under the IND (e.g., a specific protocol or part of a protocol is not allowed to proceed; however, other protocols or parts of the protocol are allowed to proceed under the IND).

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