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Home / Business / Bristol Myers hinted at some issues with the necessary FDA inspection for liso-cel OK, and panicked Celgene CVR investors – Endpoints News

Bristol Myers hinted at some issues with the necessary FDA inspection for liso-cel OK, and panicked Celgene CVR investors – Endpoints News



Investors holding relative value of $ BMYRT from the Celgene acquisition are giving way to today’s panic.

During their third-quarter call with analysts, the regulators said the FDA checked the Bothell, WA plant used for liso-cel (JCAR017), CAR-T Bristol Myers selected in the deal. That is a plus.

But there’s one catch.

They went on to say that no inspections were even scheduled for the CMO Texas involved. And with that, investors slowly dripping out of the CVR group turned into an instant roadmap. Shares are down about 80% from still $ 3.40 for CVR late yesterday. That brought it down to coin stock territory.

Why step on?

Salim Syed

Remember that in the last-minute buyout negotiations, Bristol Myers CEO Giovanni Caforio insisted that they replace the cash on the table with a $ 9 CVR tied to the approval of 3 drugs on certain date. Ozanimod has already set a deadline, but the fates of liso-cel (JCAR017) and Ide-cel are being hung on FDA actions. Liso-cel was delayed and Ide-cel was slapped by a name that refused to apply. That medicine must not be effective until the end of the first quarter of next year.

As Bristol Myers notes in its 3rd quarter presentation today, there is a PDUFA date on November 16 for liso-cel and without the clean health bill on the CMC, regulators are incapable of accepting Received a one-time closely watched therapy that won a groundbreaking position at the FDA. That could cause another significant delay.

Salim Syed of Mizuho, ​​who is following every little detail around the work of CMC – including the personal eye reports complete with telephoto lenses during Bothell’s test – summarized it in here:

The way it came up in the call was this because COVID-19 and the FDA wanted to keep their employees safe. However, investors had come to expect and what seemed most plausible was to test the plants together closely in sequence, Bothell and Texas.

Syed, though, was urging calm in the chaos. Although the PDUFA is on November 16, the CVR deadline is later this year – still a few weeks away.

Remember, FDA only needs to be here for ~ 3 weeks (by our reasonable standards and KOL call) post-check to finish all the paperwork and get the medicine to the destination.

Additionally, he adds, this is a BTD program, so the FDA should get ready quickly. Executives at Bristol Myers have never said whether there is a virtual audit possible and besides, the company has said that if they knew they were going to miss the PDUFA, they would say it immediately.

So far, very good at that score. The PDUFA remains the same.

But with the deadline very close, a lot of investors are getting started.




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