Within drug development circles, there’s nothing quite as embarrassing as a refuse-to-file letter from the FDA. So it’s probably no big surprise to hear that the average biopharma outfit prefers to hide under any available rock before frankly explaining what derailed their applications right from the start.

FDA staffers took a close look at 103 RTF letters — out of 2,475 applications, or 4% of the total — that were sent privately to drug developers, counting 644 reasons why the agency barred the door to a new drug application. The agency’s hands are tied on public disclosures, though, leaving it to the companies to offer an explanation. And that has left companies free to either publicly ignore what happened, or simply mislead people about the setback.

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Bernstein analyst Ronny Gal has some good news and some bad news related to the pandemic.

So what do you want to hear first?

It’s the end of the week, so let’s start off on something sweet before we turn to the sour.

In Gal’s seasoned opinion, there are positive notes being sounded in the fight against Covid-19. These new variants, he writes, are still being knocked back by the approved vaccines, and the mRNA jabs from Moderna and Pfizer/BioNTech demonstrated enough of a knockout punch against the Brand A virus to allow for a drop of efficacy on the variants while still offering herd immunity.

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CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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John Connolly, the new chief scientist at the Parker Institute for Cancer Immunotherapy, has a fresh mission on his plate.

Connolly’s been tapped to take the interim CEO spot at 3T Biosciences, a buzzy Bay Area startup that’s joined the whole cell therapy 2.0 movement with the help of 2 tech billionaires who have shown a big interest in cancer drug development: Peter Thiel and Sean Parker, who lent his name and direct involvement to his eponymous nonprofit.

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