Hi @SpanSpan Do fairy tales come true? Not often, and I'm first...

Hi @SpanSpan Do fairy tales come true? Not often, and I'm first to admit I'm among the legion of LT holders who were very disappointed by what the FDA's done in the last couple of days, but also holding to the notion that a Randomised Controlled Trial (RCT), particularly for Covid-19, is the gold standard and there won't be any of the subjective FDA tinkering we've seen for aGvHD.

The question here is what impact the Trump infection will have on the MSB's Phase 3 trial and the company more generally. The 'first data' from the Regeneron Phase1/2/3 trial was only discussed 3 days before the President's physician, in the White House, decided to give him the biggest dose (8 mg). When you read the media release on the Regeneron site, it indicates that of the trial population (numbering in the thousands), about 40% already had their own immune system started and 40% didn't (seropositive and seronegative). The -ive's took longer to clear the viral load from their system, so let's hope the President's immune system was already kicking in. But did he get the biggest dose of an experimental drug out of an abundance of caution, or because he was seronegative and they were trying to kickstart his immune system? It is telling that he got flown to hospital but Melania didn't and it's now been reported he's got mild symptoms. That 20 second video he took in the WH and his walk onto and off the chopper taking him to hospital showed the 'fatigue' that his doctor is reported to have mentioned. The next 7 days (median) are critical as to the effect of Regeneron on DJT.

The early data (see graphs below) show he is slap bang in the middle of two age groups (from 65-84 years) and which indicate that the hospitalisation rate is lowest at 28.6% and highest at 58.7%. And this was a group that was 40% obese, so if Regeneron doesn't work, DJT's chances of 'hospitalisation' are likely at the higher end, which appears to be when breathing/lung difficulties are first reported for the ambulances to come around. The coughing and bone soreness etc. not requiring an ambulance and can still be treated at home.

And no, I don't think he will be included in MSB's Phase 3 trial as opposed to given compassionate access to it. The Regeneron precedent already indicates a preparedness to use FDA-unapproved therapeutics (and a preparedness to tell all the world about it). For one, it seems a bit arbitrary to me as to when you are 1-3 days on a ventilator to pump oxygen into your lungs, depending on the doctor you have, how you present at the hospital and how many ventilators are around. Surely, the technical indicators of the respiratory distress and the cytokine storm will be apparent many days before then (hence this is now being monitored in a hospital environment whilst he can still walk through the front door). And secondly, this is the US President, there are no two of him for there to be any appetite to risk a 1:1 placebo. And thirdly, can you imagine the global ructions if the news release is that the President is on a ventilator?

So remestemcel-L HAS to be on standby, I think, for the first signs that emerge along that spectrum of indicators that leads to ICU and ventilator. And for a therapeutic which carries no risk, but where the suspicion is that the sooner you use it, the sooner you prevent the cytokine storm that damages heart, blood, organs and brain, what are the doctors going to do having already shown that they are prepared to take the maximum risk with 8 mg of Regeneron? Just one favour - don't store it in the Walter Reed storeroom where other chemicals are kept, and certainly don't send a certain individual to fetch it (even though he may want the exercise).

In writing a fairytale, you always have to go back to the start of the story, which in this case is the FDA's recent decision. If DJT gets the MSB treatment and resumes his re-election campaign, what will that aGvHD meeting with the FDA in 30 days' time look like? Ego alone would suggest that the FDA won't spin on a dime and change its mind so soon after making it up. But what if the President gets a dose of the very thing you are refusing to register for no good reason if the sponsor is willing to conduct the adult RCT you are seeking?

DYOR of course! I'm a disappointed LT holder, and I hope to inject a smile on your faces for the weekend. This world has gone crazy in 2020 and Covid-19 is the biggest game in town (some say the only game). Fairy tales are normally scarcely believable, but did anyone in 2019 believe this is what 2020 would look like?

Stay safe, all PLEASE. Let's just wish each other some peace and goodwill.

TABLE. Hospitalization, intensive care unit (ICU) admission, and case–fatality percentages for reported COVID–19 cases, by age group —United States, February 12–March 16, 2020

Age group (yrs) (no. of cases)%*HospitalizationICU admissionCase-fatality0–19 (123)1.6–2.50020–44 (705)14.3–20.82.0–4.20.1–0.245–54 (429)21.2–28.35.4–10.40.5–0.855–64 (429)20.5–30.14.7–11.21.4–2.665–74 (409)28.6–43.58.1–18.82.7–4.975–84 (210)30.5–58.710.5–31.04.3–10.5≥85 (144)31.3–70.36.3–29.010.4–27.3Total (2,449)20.7–31.44.9–11.51.8–3.4

* Lower bound of range = number of persons hospitalized, admitted to ICU, or who died among total in age group; upper bound of range = number of persons hospitalized, admitted to ICU, or who died among total in age group with known hospitalization status, ICU admission status, or death.