Mark your cal­en­dars for No­vem­ber 14.

Af­ter slow­ly and cau­tious­ly rais­ing its hopes to the point where com­pa­ny ex­ecs be­lieved an Ad­Com on its sup­ple­men­tal la­bel for Vas­cepa was “un­like­ly,” the biotech put out word late Thurs­day that the FDA has pen­cilled in an ex­pert pan­el meet­ing for them in mid-No­vem­ber.

And in­vestors — who were grow­ing in­creas­ing­ly warm to the idea that the com­pa­ny could be on a cake­walk to a cru­cial, and po­ten­tial­ly block­buster, ap­proval on the Sep­tem­ber 28 PDU­FA date — pan­icked. Shares $AM­RN plunged 22% on the news.

That PDU­FA date next month?

You can prob­a­bly scrap that as well.

Amarin does not ex­pect the FDA to take ac­tion on the sN­DA by the pre­vi­ous­ly an­nounced Sep­tem­ber 28, 2019 Pre­scrip­tion Drug User Fee Act (PDU­FA) goal date. Amarin did not re­ceive no­tice from the FDA of a PDU­FA date ex­ten­sion. In light of the ten­ta­tive Ad­Com date, Amarin an­tic­i­pates that the PDU­FA date will be ex­tend­ed, as­sum­ing a typ­i­cal three-month ex­ten­sion, to a date in late De­cem­ber 2019. If so, this an­tic­i­pat­ed re­vised PDU­FA date tim­ing would off­set three of the four months that were ex­pect­ed to be gained from FDA’s ear­li­er de­ter­mi­na­tion to con­duct a pri­or­i­ty re­view of the RE­DUCE-IT sN­DA.

An Ad­Com on Vas­cepa isn’t nec­es­sar­i­ly the end of the world, by any means, for Amarin boost­ers. But it will be an op­por­tu­ni­ty for FDA in­ves­ti­ga­tors to air every ques­tion they have about the da­ta and in­vite their ex­perts to scru­ti­nize any weak point in their ap­pli­ca­tion.

As it stands, the com­pa­ny has had every op­por­tu­ni­ty to boast of the sig­nif­i­cant car­dio ben­e­fits their in­ves­ti­ga­tors re­port­ed on RE­DUCE-IT, and any word to the con­trary could ding its prospects among pay­ers. On the oth­er hand, a clear vote in its fa­vor would mark a big en­dorse­ment for the drug as Amarin beefs up its staff in prepa­ra­tion for a great­ly ex­pand­ed mar­ket­ing cam­paign.

Sometime in the 1st century AD, a patient presented to Arataeus looking like a varicose ghost. He was “emaciated and atrophied, pale, feeble and incapable of performing any of his accustomed works,” the Greek physician wrote, with hollow temples and huge veins running all over his body.

A dysfunctional digestive system, Arataeus concluded – an imbalance he attributed to a “heat” deficiency in a system he and other Greeks regarded as functioning similarly to an oven – and coined a term: coeliac disease, after the Greek word for abdomen.

In June 2017, Leah Christl, former biosimilar lead at FDA, told a conference in Chicago that interchangeable biosimilars were likely coming to the US market within two years.

And although no interchangeable biosimilar has been approved by FDA yet, and Christl has since moved on to Amgen, progress on interchangeable biosimilars has been slow in the intervening years.

Most recently, Boehringer Ingelheim announced that it has completed, as of last April, a switching study necessary for launching an interchangeable biosimilar for Humira (adalimumab), although the company did not offer any further details on the timing of its submission to FDA or whether there will be an advisory committee to review the data. Boehringer already has an adalimumab biosimilar approved by FDA, which it will launch in the US on 1 July 2023.

Tiny Assertio Therapeutics’ shares plunged pre-market on Tuesday, after the FDA has spurned its man-made version of the hormone ACTH, which was being reviewed as a diagnostic for patients presumed to have adrenocortical insufficiency.

The Lake Forest, Illinois-based drugmaker said its development partner West Therapeutic Development had received a complete response letter from the US regulator, which indicated that that certain “pharmacodynamic parameters were not adequately achieved” for the product.

Bayer committed $300 million to set up a joint venture on CRISPR/Cas9 tech with CRISPR Therapeutics $CRSP. But they’re handing off control now to the smaller biotech while retaining a couple of opt-ins for programs nearing an IND.

Bayer $BAY made much of the fact that they were going all-in on gene editing when they did their deal 3 years ago with CRISPR Therapeutics, which pitched $35 million in on their end. This was the cornerstone of their plan to set up new JVs that could make some serious leap forwards in hot new R&D spaces. Now CRISPR will have full management control of Casebia as they pursue programs in hemophilia, ophthalmology and autoimmune diseases.
Samarth Kulkarni, the CEO at CRISPR, made it sound like a natural progression.