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I assume the subject of Accustem was avoided at all costs
Mutagenic
I’m sure whatever the requirements are they will have received the guidance but I’m in agreement that I wouldn’t expect it to be a very low patient figure to gain approval however as the process is different I'm still optimistic that they can achieve their goals despite some of the hurdles they may have to face as it looks like covid is going nowhere for now.
So when will we know it works? If the trial actually starts on time completion is not until May
Uk gov are twats!
Foralumab of course!
Molnuparivir does not come with a health risk warning as it still hasn't received EUA.
Although that hasn't stopped the UK government from pre ordering it!
If it works it works!
Yes it does, I’ve forgotten the drug but I googled it and it came with a health risk warning!!
It's quite clear that the process is different for EUA. The FDA will still want to see more data than 80 patients in Brazil.
Again, why would you talk about EUA when you haven't even started the trial?
It doesn't come with a health risk warning other than info on side effects. Some scientists have suggested it could cause cell damage but that was not present in the trial data.
Are you disputing what has been written in the article about the process for EUA not being the same as gaining normal FDA approval ? If anything they will be seeking guidance from the FDA on their next stages so whether it’s 80 or over 1000 I’m sure they will be fully informed.
Agreed Sangi but you’d think that they would at least give it a go ,as no one has died yet from taking it or had an extreme adverse reaction , as milciclib has shown as well , what’s up with these people. The latest anti viral repurposed by Merck comes with a health risk WARNING ffs.
I am afraid the FDA are not going to approve based on your say so Cloudy.
They will want to see comprehensive trial data.
And surely you would get on and do the trial and then present the data to the FDA rather than telling investors you are going to apply for EUA before the trial is done.
They are doing the trial to see if Foralumab works. Data from the first trial was very inconclusive. So until they do the trial and get results they have no business telling investors that they are going for EUA
Sangi, Foralumab has an excellent safety profile cos there are not sticking it in your arm!!
So why are Merck providing data for Molnuparivir in 1850 patients instead of just 80?
Or from your article link the GSK/Vir candidate Sotrovimab was given EUA following a Phase 3 trial in over 1000 patients
Foralumab or will have! ! Not ramping!!
Gaining EUA for covid 19 use is not the same as gaining normal FDA approval https://www.news-medical.net/health/Monoclonal-Antibody-Treatments-in-COVID-19.aspx
The fact that they are running the trial in Brazil again using the excuse that they can't afford to do in the US is a bit odd as well.
4D are running a cancer trial at 5 different US locations in 130 patients as well as other UK trials
on a cash burn of about £25m.
I think it is more like they can't get authorised to do the trial in the US due to the FDA scepticism of the safety profile of anti CD3 drugs.
Cloudy
There is being positive and talking nonsense.
I still call it ramping. You also know you are ramping.
Name me a Phase 2 covid trial of less than 100 people that has got a FDA EUA.
They would need to actually get a trial started for that to happen
If they come out of hospital singing and dancing ………Howard Weiner did actually say ‘ if nothing else it works’……!!
What happened to the CTAP grant they said they had applied for?
Any update on that?
23rd June announced a second covid trial to start in Brazil
Nearly November and still hasn't started.
Any explanation as to why?