BMYYRT from Selgen Buyout, which has retained its contingent value rights, is giving way to panic today among investors.
During his Q3C call with analysts, Exxon said the FDA had inspected the Bothel, WA plant used for lyso-cell (JCAR 017), CAR-T Bristol Myers was taken into account in the deal. That’s a plus.
But there was a hitch.
He went on to say that no inspection has yet been scheduled for the Texas CMO involved. And with that, the slow pace of investors exiting the CVR group turned into an instantaneous route. The stock plunged nearly 80% from the remaining 3.40 dollars for CVR at the end of the day yesterday. He took it down to the penny share area.
The Bristol CVRA said on the call that they took another turn after inspections of the Lonza facility have not yet been scheduled. $ BMYRT
– Brad Loncar (@ BradLoncar) November 5, 2020
Why the stampede
Salim SyedRecall that during last-minute buyout negotiations, Bristol Myers CEO Giovanni Caforio insisted that they replace the cash on the table with dates 9 CVR and bind with approval of 3 drugs by a certain date. Oznimode set a deadline, but Liso-Cell (JCAR01) and future FDA are hanging on to actions. Liso-cell was late and slapped with ide ide-cell refusal-to-file. That is until the end of Q1 next year to make the drug better.
Bristol Myers notes in its Q3 release today that the November 16 PDUFA date for Liso-Cell is approaching, and without a clean bill of health at CMC, regulators are unlikely to come up with a fix for what was once closely watched. Therapy that achieved success status on the FDA. It could spell another significant delay.
Salim Syed at Mizuho, who is exploring every little detail surrounding the CMC’s work – including private eye reports with telephoto lenses on the Bothel observation – is summarized here:
The call was coached on the way that this is due to COVID-19 and the FDA wants to keep its employees safe. However, investors were expecting, and in what seems to be the most logical sense, in order to inspect the plants together, Bothel and Texas.
Syed however urges to remain calm in the melee. While Pidufa is on November 16, the deadline on the CVR is the end of this year – there are still a few weeks left.
Remember, the FDA only needs about 3 weeks of supervision (by fair standards and our KOL KL) to complete all the paperwork and get the drug to complete the finish line.
Also, he adds, this is a BTD program, so the FDA should be prepared to hurry. Exxon at Bristol Myers never said if there could be a virtual inspection and besides, the company had already said that if they found out they would miss the PDFFA, they would say right away.
So far, so good on that score. PDUFA is in its place.
But with the deadline drawing, too close, many investors are bolting.
