This is all a load of speculation.
If the FDA is the reason for the delay, maybe either they haven't looked at the application yet at all, or maybe they are waiting a response from Lonza, or they are just behind.
If it is the company that is delaying 1 or 2 days, it doesn't make a difference since it is in trading halt, and potentially they are delaying so that the announcement along with whatever is happening / required on their side is correct and not just the FDA headline rushed out the door.
We should also be close to a DMC readout around now so that is another spanner if that has happened and they will announce both bits of news together, possibly because the use and manufacturing is somewhat linked.
All speculation though, it could be NO / YES with strings, and YES
Just remember whatever the outcome- Heart Failure Readout is just around the corner!
Ann: Trading Halt, page-407
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