Member Info for Sangijuelas1

I think the top line analysis, where the results were so much stronger in the larger US cohort, especially women, has impacted their plans.

In the recent Blautix presentation they were very guarded whereas previously they had been more open about discussions with potential partners.

This suggested to me that they see more value in Blautix than a few months back and maybe less willing to profit share by out licensing.

They did a small capital raise last year for about £7m to tide them over so maybe they would do another purely to fund Blautix P3 given that other funding is earmarked for 0518, Asthma and getting the Parkinsons trial up and running.

Especially Tinners since we have a Prime Minister who has said much, much worse things.

www.businessinsider.com/boris-johnson-record-sexist-homophobic-and-******-comments-bumboys-piccaninnies-2019-6%3famp

Rule No. 1
Knowing Sharebel as I do if pumping a stock (Braveheart, Tils, Amigo) get the **** out.

If deramping buy as much as you can

I have started to think something, which is purely a suspicion on my part and not an accusation as it is not based on any facts.

I think it is possible that one of the aims of the Brazil trial was to dose some patients with Foralumab, in order to get more safety data that they could present to the FDA, who are wary of anti CD3 drugs . GC alluded to this in recent interview.

My thinking is influenced by goings on at 4D. Covid meant that they could not proceed with their asthma trial as planned. They got emergency approval to use the same drug to treat covid patients. This never went ahead as they were unable to recruit patients but if it had it would have generated safety data that could have been used to make up for the lost ground on the asthma trial. Now the asthma trial has completed recruitment and they have formally dropped the Covid trial.

I think for whatever reason the FDA were not satisfied with the safety data from the Brazil trial, which could have been used to start the full P2 in MS and Crohn's.

As things stand, the company is having to generate more pre-clinical data in mice as well as running the individual expanded access program in 1 patient.

When it comes to talk of Covid they recently seem to have been talking more about TZLS-501 rather than progressing Foralumab.

I wish the company and its investors well. As I said I didn't like some of the comms around the missed timelines. It may be the case that the FDA are being overly cautious about anti CD3 drugs and this is holding the company back. Maybe some of the comms have been their attempt to keep US investors engaged given the delays.

Can you show me 1 post that I have made where I have alleged that the company is a scam?

I have highlighted the delays to the trials, questioned why data is not available for independent verification and complained about a lack of clarity and mixed messages in the interviews.

A guy on Stocktwits did use the word scam and I didn't agree with him on that, although I didn't call him out for it.

I have asked the company questions, so they have my details. As an investor or former or potential investor you are allowed to ask a company questions to follow up on news statements and filings that have been made.

Clearly I am just a retail investor with gaps in my knowledge. It seemed strange to me that there was nothing on clinicaltrials.gov for the Foralumab trials in healthy volunteers, which is supposed to be the basis for the MS and Crohn's phase 2.

I have now discovered that registering a P1 trial is voluntary, not mandatory. Some suggest that registering a trial is good practice and it is a condition for publishing results in an academic journal and often trial ethics committees insist on it.
https://clinicaltrials.gov/ct2/manage-recs/background

It seems investors here are incapable of honestly questioning what's going on. Who can really say they are happy given the progress made by SNG up to P3 compared to Tils?

In the small print of the P1 Brazil trial were the words exploratory study. Effectively Phase 0.

How the hell are the FDA, the EMA and the MHRA going to approve Foralumab for Covid on the basis of a trial in Brazil?

Maybe they will do a trial and approve it there. After all they approved Ivermectin!

https://www.nature.com/articles/d41586-020-02958-2

Register gets updated every Monday I think so maybe will know before the end of the day or RNS Monday morning

Johnnie your posts are always very insightful

Still looks a bit **** though if anyone clicks on the board.

I just got some more anyway as they are giving them away

We have a dozen or so posts with the headline telling everyone to sell.

Great work guys. Your job in marketing awaits!

Ok final word from me on this.

So I have now confirmed to my satisfaction that the company does not have to mandatorily register each Phase 1 trial on the FDA register.

I have seen lots of of Phase 1 trials on the register but these would have been voluntary submissions.

If they were dosing Foralumab with healthy volunteers there would have to be a record of it with a regulator as it's normally a condition of liability insurance.

This is the record for the Novimmune Phase 1 for NI 0401 which is Foralumab
https://clinicaltrials.gov/ct2/show/study/NCT00630643
Tils licensed Foralumab from Novimmune who did a trial of it in 2008 under the name NI-1401.

It was intravenous and for Crohn's. Safety results don't look great. They planned to start dosing at 10mg but found that 2mg was the level where adverse events got bad. Here's a quote from the section on safety.

“Following the completion of the treatment period and during the remaining 6-month observation period, 85% of the patients reported at least one study drug-related AE. Infections were reported by 17 patients. Six were considered drug-related of moderate or severe intensity. Five were reported as moderate: one in each of the placebo and treatment groups between 0.05 and 2 mg. The reported infections were respectively: nasopharyngitis, perianal abscess, an infected ear lobe, an oral fungal infection, and herpes labialis. The only AE graded as a severe infection was an acute tonsillitis that occurred in the 10-mg patient"

The primary endpoint for clinical benefit was not met at the 1g dose.

"Although NI-0401 was designed to limit drug-induced cytokine release, its administration at the intended concentrations resulted in acute IRRs associated with cytokine release. Treatment with NI-0401 at low concentrations is safe and was able to induce CD3 modulation; however, the clinical effect was limited".

https://academic.oup.com/ibdjournal/article/16/10/1708/4628258

This is why the data from the trial in healthy volunteers is needed.

But the answer came from an email query I first sent 2-3 weeks ago
So just trying to show that

I emailed what I received from Hana to your business email

Well maybe you aren't lying about getting a call and email, but the origins of the email are from my initial query.
I lost money here based on past company statements about trials and I am looking to verify the results.

Of course you publish result so that they can be held up to scrutiny by academics and investors .

Why do you think I got the email from the Zacks analyst?

Wow that is some lie you are telling Paul. Hana sent me the email today at 6.20 after I spoke to her this morning

There's still no published evidence of the trials though is there?
The normal process is to do a trial and then publish the results for peer review.

The email was in response to my query so all you have done Paul is receive an email that came about from this.

This still does not explain why there's no record of the Foralumab trials with the FDA.

You might be happy with all this secrecy but others aren't.

Still no response from the company with regard to questions about the lack of a public record with the FDA for the Foralumab trials they say they did in healthy volunteers.

This is getting serious now as there was a whole paragraph in the SEC fundraise filings about the trial and the FDA, in addition to the various RNS about it.

Yet there is no record of the trial on clinicaltrials.gov. I am waiting for Hana to get back to me on this with a response.

The Zacks broker who gave the positive note last week emailed me the following last week when I contacted him.

"the data has not yet been published for the most recent phase I. you are correct that it does not appear on clinicaltrials.gov I relied on the press releases provided by the company and there are working hyperlinks in our last report to both of the press releases.

I spoke with the CEO and asked if they had a poster with more data available but the only public information is the press releases.

With only the company’s characterization of the results and no hard data, we should discount management’s opinion of the results accordingly."

A bit like the trials that don't exist anywhere apart from the company announcements about them