The nail-bit­ing among the in­vestors who held on to their con­tin­gent val­ue rights $BMYRT from the Cel­gene buy­out is giv­ing way to pan­ic to­day.

Dur­ing their Q3 call with an­a­lysts, ex­ecs said that the FDA had in­spect­ed the Both­ell, WA plant be­ing used for liso-cel (JCAR017), the CAR-T Bris­tol My­ers picked up in the deal. That’s a plus.

But there was a hitch.

They went on to say that no in­spec­tion had yet even been sched­uled for the Texas CMO in­volved. And with that, the slow trick­le of in­vestors seep­ing out of the CVR group turned in­to an in­stant rout. The stock plunged about 80% from the $3.40 still left for the CVR at the end of the day yes­ter­day. That took it down in­to pen­ny stock ter­ri­to­ry.

Bris­tol CVR took an­oth­er turn down af­ter they said on the call that an in­spec­tion of the Lon­za fa­cil­i­ty has not yet been sched­uled. $BMYRT

— Brad Lon­car (@brad­lon­car) No­vem­ber 5, 2020

Why the stam­pede?

Sal­im Syed

Re­mem­ber that dur­ing last-minute buy­out ne­go­ti­a­tions, Bris­tol My­ers CEO Gio­van­ni Caforio in­sist­ed that they re­place cash on the ta­ble with a $9 CVR tied to the ap­proval of 3 drugs by cer­tain dates. Ozan­i­mod made the dead­line, but the fate of liso-cel (JCAR017) and ide-cel are hang­ing on FDA ac­tions. Liso-cel was de­layed and ide-cel got slapped with a refuse-to-file. That drug has un­til the end of Q1 next year to make good.

As Bris­tol My­ers notes in its Q3 pre­sen­ta­tion to­day, there’s a Nov. 16 PDU­FA date loom­ing for liso-cel, and with­out a clean bill of health on CMC, reg­u­la­tors aren’t like­ly to come through with an OK for a once close­ly-watched ther­a­py that earned break­through sta­tus at the FDA. That could spell an­oth­er sig­nif­i­cant de­lay.

Sal­im Syed at Mizuho, who’s been track­ing every tiny de­tail around the CMC work — in­clud­ing pri­vate eye re­ports com­plete with tele­pho­to lens­es on the Both­ell in­spec­tion — summed it up here:

The way it was couched on the call was that this is due to COVID-19 and the FDA want­i­ng to keep its em­ploy­ees safe. How­ev­er, in­vestors were ex­pect­ing, and what seemed to make most log­i­cal sense, is to in­spect the plants to­geth­er close­ly in se­quence, Both­ell and Texas.

Syed, though, is urg­ing calm in the melee. While the PDU­FA is dat­ed Nov. 16, the dead­line on the CVR is the end of this year — still some weeks out.

Re­mem­ber, the FDA on­ly needs here about ~3 weeks (by rea­son­able stan­dards and our KOL call) post-in­spec­tion to fin­ish up all the pa­per­work and get a drug to the fin­ish line.

Be­sides, he adds, this is a BTD pro­gram, so the FDA should be will­ing to hur­ry up. The ex­ecs at Bris­tol My­ers nev­er said if there could be a vir­tu­al in­spec­tion and be­sides, the com­pa­ny al­ready said that if they learned that they would miss the PDU­FA, they’d say so prompt­ly.

So far, so good on that score. The PDU­FA re­mains in place.

But with the dead­line draw­ing very, very close, a lot of the in­vestors are bolt­ing.

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.