Ann: Trading Halt, page-566

No, they may very well have notified Mesoblast of the decision but informed them that they are not permitted to release the information until FDA has gone through the proper disclosure review. Read their internal policy document.

Office of New Drugs (OND) regulatory project manager (RPM) assigned to the NDA or BLA:

1. Check the approval or tentative approval letter with any enclosures (e.g., final agreed upon labeling text, REMS) into the electronic archive.

2. Ensure a copy of the signed approval or tentative approval letter, with any enclosures, is promptly sent via a rapid form of communication, such as fax or secure email, to the applicant’s official regulatory contact. Confirm applicant receipt of the letter.

3. If a press communication has been prepared, the RPM will notify the press office as soon as receipt of the approval letter has been confirmed by the applicant.

As soon as Mesoblast got the notification, they would have arranged the trading halt. But they may be prevented from announcing until FDA clears them to do so. I am not an expert with the kind of experience needed to be sure about any of this. I am simply trying to research FDA policies and doing my best to interpret them. Still struggling to find anything that specifically says FDA can notify a company of a decision but force them to hold an announcement until FDA makes the announcement themselves, or at least until FDA completes their internal review procedures for publication, which appear to be more extensive for approvals expected to generate a lot of press interest.