When French vac­cine mak­er Val­ne­va signed a pur­chase agree­ment with the Eu­ro­pean Com­mis­sion in No­vem­ber, ex­ecs tout­ed how the deal — un­der which it would sup­ply 60 mil­lion dos­es of its in­ac­ti­vat­ed, ad­ju­vant­ed whole-virus Covid-19 vac­cine — of­fered an al­ter­na­tive to the mR­NA and ade­n­ovirus-based shots al­ready out there.

But the whole deal may be in jeop­ardy now.

The EC first sent a no­tice of in­tent to ter­mi­nate the pur­chase agree­ment back in May, as the reg­u­la­to­ry re­view of Val­ne­va’s vac­cine stalled. De­spite propos­ing a re­me­di­a­tion plan, Val­ne­va dis­closed Fri­day that the lat­est dis­cus­sions sug­gest the chances of reach­ing a re­vised deal are slim.

Val­ne­va shares (EPA: $VLA) plunged 26% to €7.70 on the Paris stock ex­change.

While the EMA be­gan its rolling re­view of Val­ne­va’s shot in Feb­ru­ary 2021, reg­u­la­tors still had ques­tions as re­cent­ly as Feb­ru­ary. Un­der the orig­i­nal deal, the EC had a right to pull out of its pur­chase if Val­ne­va had not re­ceived mar­ket­ing au­tho­riza­tion by April 30 — and it didn’t (al­though the UK did au­tho­rize it in mid-April).

In re­sponse to the EC’s no­tice of in­tent, Val­ne­va pro­posed a re­me­di­a­tion plan. How­ev­er, the “pre­lim­i­nary, un­of­fi­cial vol­ume in­di­ca­tions” the EC got from the few mem­ber states that ex­pressed in­ter­est in the in­ac­ti­vat­ed shot “would not be suf­fi­cient to en­sure the sus­tain­abil­i­ty” of the pro­gram, not to men­tion fur­ther de­vel­op­ment.

If those or­der num­bers be­come fi­nal, Val­ne­va sug­gest­ed the re­duc­tion would be so dras­tic that it like­ly won’t en­ter in­to an amend­ment. That could spell an end to any ac­cess hopes.

In a state­ment, CEO Thomas Lin­gel­bach said he hopes the EC and mem­ber states will re­con­sid­er.

“There is emerg­ing ev­i­dence that hy­brid im­mu­ni­ty – from a com­bi­na­tion of vac­ci­na­tion and nat­ur­al in­fec­tion – in­creas­es pro­tec­tion against de­vel­op­ment of se­vere Covid-19 caused by dif­fer­ent vari­ants of con­cern, and our in­ac­ti­vat­ed vac­cine close­ly mim­ics nat­ur­al in­fec­tion by ex­pos­ing vac­cines to the en­tire in­ac­ti­vat­ed SARS-CoV-2 virus,” he said. “Ad­di­tion­al­ly, mar­ket re­search stud­ies in six Eu­ro­pean coun­tries in­di­cat­ed ma­te­r­i­al in­ter­est in an in­ac­ti­vat­ed Covid-19 vac­cine for pri­ma­ry or boost­er vac­ci­na­tion. We con­tin­ue to re­ceive mes­sages from peo­ple look­ing for a more tra­di­tion­al vac­cine tech­nol­o­gy and we hope to re­ceive a mean­ing­ful or­der size to fur­ther sup­port pub­lic health in Eu­rope.”

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.