The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
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I must have missed some info , can any give me an idea on when the new US shares will start to trade ? Many Thanks
I didn’t manage to listen to it but heard MS is going good with no problems and if Covid trial goes as it should , emergency use FDA will be on the cards. GLA
A trial for 80 people in Brazil is not going to lead to an emergency use approval.
Merck are applying for EUA following a trial with 1850 patients and they are not certain to get it.
If they were saying that and I was still invested here I would be quite concerned.
It is going to be near impossible for FDA approval on a Phase 2 trial with only 80 patients.
Even Phase 3 trials with 800 patients are not getting FDA approval or EUA.
Cloudy you should not ramp.
It is not fair on inexperienced investors who may take your comments seriously.
Tils has been ramped enough.
Give it a rest and let the price go up when it is ready and not artifically.
To be fair to Cloudy it sounds like he is just repeating what was said in the investor call.
It's a bit like when Tizzy claimed to have initiated a clinical trial in MS when all they had done was get accepted to do compassionate use of Foralumab in one MS patient
https://mobile.twitter.com/TizianaLS/status/1397147081329029121
23rd June announced a second covid trial to start in Brazil
Nearly November and still hasn't started.
Any explanation as to why?
What happened to the CTAP grant they said they had applied for?
Any update on that?
If they come out of hospital singing and dancing ………Howard Weiner did actually say ‘ if nothing else it works’……!!
They would need to actually get a trial started for that to happen
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.
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.
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
Foralumab or will have! ! Not ramping!!
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
Sangi, Foralumab has an excellent safety profile cos there are not sticking it in your arm!!
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
I am afraid the FDA are not going to approve based on your say so Cloudy.
They will want to see comprehensive trial data.
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.
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.
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.
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?
Yes it does, I’ve forgotten the drug but I googled it and it came with a health risk warning!!
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!