Parameters of the trial
Expanded Access Type
"Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA.
This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA."
So ....this trial is happening because there has been .......multiple patients with the same disease or condition seeking access to a specific drug or biological product that has not been approved by the FDA.
Ask yourself this one question ......Where have these people heard of MSB treatments and not just heard but heard enough to specifically request access to their treatment??
Answer it is to me quite obvious..... that news is leaking out in the USA medical system about results from MSB's ARDS adult trial and MSB's treatment options from their previous trials IMHO ....nothing else makes sense.... as to how the patients or their families would know to request MSB's treatment to be tried on their children and adolescents
My mum knows a lot about Clinical trials.....how they are run...... and how these sorts of new knowledge spreads amongst medicos ....new treatment looking good worth a try have a look at this one .....etc etc....until eventually there's enough people get informed and start telling families about asking for a particular treatment .....that they have to start a trial.
Look at the comments from the NY intensive care nurse to see that ...that kind of news spreads quick amongst medicos ....especially when it's kids who are sick and there might be something being used on adults that is seeing results ....I said before way back to keep an eye out for the issues Covid would create for children ....it's one thing to say oh well it's just the oldies getting sick and dying..... it's another thing entirely when kids are at risk. For me all people matter .....it's stunning to think there are 125000 Americans who have lost their lives to Covid 19 ....that's a national tragedy any way you try and frame it and that is just one country. But as soon as you involve kids.... the stakes go up and that's when people demand answers and treatments. This is what I think we are seeing here a groundswell of demand being driven by reports of success in adults leaking out
Cheers
(20min delay)