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So when will we know it works? If the trial actually starts on time completion is not until May

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!

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.

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

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

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.

They would need to actually get a trial started for that to happen

You also get people posting that Tizzy has some amazing patents on nasal spray delivery systems etc.

They don't. They have patents on novel formulations of Foralumab so as it can be administered as a pill or liquid, dosed with a nasal spray.

In the Foralumab MS trial for example tyey are using the Unidose device made by the company Aptar.

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?

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

So you are saying you sold out at around the same time you were ramping the stock as per Ax posts on your previous comments that it was going to 300p?

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.

See slide 15 on the new investor presentation.

In the updated investor presentation there's a slide that says that 0518/ Flagellin is being investigated for potential TLR9 activation. (It already has TLR5 signalling confirmed)

This is part of the innate immune system activation. TLR9 is often activated by synthetic agents that are shown to be very effective vaccine adjuvants in pre clinical trials.

So this new angle of TLR9 activation by 0518 could have come from the vaccine research as it has never been mentioned in any of the readouts from the oncology trials.

This article by the Merck scientists also references Flagellin in vaccines

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8155485/

BBC article mentions Flagellin at the end.

"One candidate is the protein flagellin. It’s found in bacteria such as Salmonella, which use it in their tails, or flagella, to propel themselves around. Sometimes it’s made by detaching the tails from bacteria – though more recently it’s become common to grow it in genetically modified cells.

Flagellin isn’t yet licensed for use in any human vaccine, but it’s shown promising results in trials.

During a natural infection with bacteria, the protein binds to receptors on the surface of immune cells. This acts like a danger signal and encourages them to tell other immune cells to flock to the site – leading to a protective response. In theory, this is also what happens when it’s included in vaccines. As with other adjuvants, it gets the attention of the immune system, so that the vaccine can do its job."

https://www.bbc.com/future/article/20201027-what-is-added-to-vaccines

I have said it before and I have just seen some further evidence that has bolstered my belief.

I think one of the vaccine adjuvant candidates is MRx0518. This because 0518 produces a very potent form of the protein flagellin, which is seen to have a lot of potential as a vaccine adjuvant. It is mainly mentioned in relation to flu vaccines.

I am staying long as I believe Merck will buy 4D sooner or later.