Bristol Myers’ $9 Celgene CVR is teetering on the brink of disaster as the FDA delays the liso-cel application yet again

The CVR ($BMYRT) tied to Bristol Myers Squibb’s big Celgene buyout took one more step right to the brink Monday afternoon.

As some analysts had fretted about, the FDA was unable to schedule an inspection of one of the manufacturing sites that was to be used for the production of liso-cel, their CAR-T picked up in the buyout, which was originally developed by Juno. As a result, Bristol Myers reported today that the FDA will not meet its PDUFA date today.

And it has no idea when that inspection can be scheduled for.

From their statement:

The FDA was unable to conduct an inspection of a third-party manufacturing facility in Texas during the current review cycle due to travel restrictions related to the COVID-19 pandemic. Therefore, the FDA is deferring action on the application until the inspection can be completed. The application remains under review. The FDA did not provide a new anticipated action date.

The liso-cel OK has to arrive by Dec. 31 — just 45 days from now — or their CVR is toast. And that’s not a lot of time for an agency that hasn’t shown much sense of urgency related to liso-cel, once one of the leading CAR-Ts in development, alongside rivals from Novartis and Kite — now part of Gilead.

Liso-cel was originally assigned a priority review at the FDA.

Remember that during last-minute buyout negotiations, Bristol Myers CEO Giovanni Caforio insisted that Celgene replace cash on the table with a $9 CVR tied to the approval of 3 drugs by certain dates. This is the second FDA delay for liso-cel and ide-cel got slapped with a refuse-to-file. That drug has until the end of Q1 next year to make good.

At one point Juno signaled their belief that an approval for liso-cel could arrive in 2018, but once in the hands of Celgene, there were repeated development delays.

Click to view original post