Analysis of the EAP, page-36

Thanks HC and Australia for the kind reception. I'm impressed by the exposure here compared to the States. A few comments:

@stokdog, certainly agree with your comments on cytokine storm. If rem-L gets approval for C-19 ARDS it will almost certainly be called upon for other forms of ARDS. The SARS-Cov-2 PCR will come back negative, but for a 25-year old crashing on a ventilator no one can r/o a false negative. I suspect that scenario will play out a lot. Will medical judgement overcome reluctance of insurance companies to reimburse for "off-label use"?

@Cato, my only focus now is trying to make judgments on likelihood of FDA approval. Someone else can count imagined riches. I would say "a lot".

@Armyne, duly noted!

@TehBlaster, Good points, I think the 72-hour limit is probably FDA imposed to reduce confounding variables that invariably appear as these patients linger on a ventilator - other forms of pneumonitis, nosocomial infections, pulmonary emboli, VILI, mucus plugs, etc. It's common in academia too, Dr Matthay's START study had 72 or 96 hours I believe. I wouldn't assume patients will be easier to treat at less than 72 hours. Any of them can descend rapidly... a lot of docs I've heard say patients look good 1 moment and a bit later they don't. I think ultimately it's the steepness of the nosedive that determines difficulty in treating. Nevertheless, it is a "purer" population of C-19 morbidity, which is why the limit is there.

@Banker, agreed. Getting intubated is not a walk in the park, I think many don't realize the import that you take your last sip of water, gasp your last few words and go under for an indefinite period maybe not to resurface. In addition to an E-T tube these patients all have central lines in the jugular, a feeding tube and a foley catheter. You're literally at the mercy of your nurses for everything. Plus families can't visit. Some of the stories in NY are... make sure you have an Advance Directive if you want to get into a trial because you aren't going to be signing papers in the ICU

@imback, Yes, one thing I didn't mention is that a big reduction in 30-day ALL cause mortality would set the gold standard for a trial like this. It's a challenge in a population with a mortality rate that high. If you look through the links Mesoblast gives in the PR, not all studies/hospitals are running above 80%. But some are, and I heard the April mortality for vented patients over the age of 65 was 97% at one hospital. Maybe the one with the refrigerator truck pulled up to the back door. Big job for the cells. Pneumococcal pneumonia used to be called "the old man's friend" due to a relatively fast and painless exit from septic shock. C-19 is "the old man's enemy", no sexism intended but old men are especially targeted by the virus. Let's hope rem-L can be the new "old man's friend". Can't say why ATHX went the way they did, I believe mortality is one of their secondary end-points. Anyone who follows me on You-hoo knows I have doubts about the efficacy of MAPCs with ATHX and IM injections in the ICU with PSTI, but all that's off topic.

ddwn, appreciate the assistance. Yes, my experience with trials is they take longer than expected. It's a lot easier to arm chair them than to do them. I would be delighted if we hear something in July, but it's pure speculation on anyone's part. Later would not surprise me. Yeah, good question on which will get approved first... I'm leaning towards Ryoncil simply because of PIMS. Advisory committee is a roadblock? FDA has been beating PDUFA dates, we'll see. If cases in the children continue to flare it could become a hot political issue due to the demographic (review the Lancet review), something's gotta give, imo

Thanks again to everyone, signing off for the evening, Left-e