Member Info for Sangijuelas1

Yeah but Rocket79, where do you think the income is from and what do you think of the Micro RX platform valuation? These must come into your calculations. I am just interested in your opinion about these fundamentals.

Some of the buying is ISA related, new tax year starts Tuesday? Is there a way to get buys in today that show as ISA funding on Tuesday?

Rocket, what are your thoughts on the income and the Micro RX platform book value?

Tell me you are having an April fool with us Xenor

Nice cut and paste from Seball post on ADVFN Rocket
DYOR

Yeah it's a good one. I got DP to answer a question on the vaccines collaboration.

This article says that Breakthrough Therapy is the best program to get on with the FDA as time from first dosing to FDA approval in under 5 years. Dosing with 0518 started about 2 years ago.

https://www.wepclinical.com/fda-approaches-speed-drug-development-approval-effective/#:~:text=Drugs%20that%20received%20Fast%20Track,and%20the%20Priority%20Review%20program.

The key thing to take into account is that 0518 could get to market before full P3 top line data is presented to the FDA, if the initial data coming out of the trials is strong enough.

This is what 4D are aiming for with 0518. This is how it was phrased in the RNS with "continue" being a key word

"to continue engagement with the FDA in 2021 to discuss the development and approval pathway for MRx0518 in combination with an ICI in patients with solid tumours and secondary resistance to prior ICI therapy".

Approval pathways could be Priority Review, Breakthrough Therapy or Accelerated Approval. The below link is an example of a Fast Track approval notice.
https://www.prnewswire.com/news-releases/moleculin-receives-fda-approval-of-fast-track-designation-for-annamycin-in-the-treatment-of-sarcoma-lung-metastases-301258271.html

Could get really interesting if 4D go for Breakthrough Therapy as this can apply where there is preliminary clinical evidence of an effect on irreversible morbidity or mortality.
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy

Celgene/ Bristol Myers Squibb got a Breakthrough Therapy Designation for Abecma the other day following a P2 trial. Rather than being apparently safe like 0518 this drug has some serious side effects but has been pushed through as benefits seen to outweigh the risks.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-cell-based-gene-therapy-adult-patients-multiple-myeloma

This is a summary of accelerated approval and the mention of preliminary evidence of tumour shrinkage without proof of life extension is interesting.
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval
Here is a link to a company that recently got an AA case through. The condition it treats has some similarities with 0518 as it treats late stage cancer that other treatments have stopped working with.
https://www.thepharmaletter.com/article/oncopeptides-gets-fda-accelerated-approval-for-pepaxto

And maybe less likely Priority Review
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review

No one has shared any useful information on 4D since my post the other day about our Capex compared to Seres and Finch.
It's all just- hopefully the price will recover, when are results due, why aren't they here
I would rather talk about the importance of Flagellin for 4D but we never have those types of discussion

There were some comments from Weiner in November about the upcoming Crohn's trial. The video was of Kunwan but I don't know if there is another Weiner one from that time discussing Crohn’s

Especially so with a low liquidity share with a small free float.
A lot of talk on ADVFN 4D board about it the last few days.

Yeah I only just found out. Quite a catch!

OK Kuurj but this is a 4D Pharma board. Not a general Spac problems board.

The other way around I think Wigscoff. It was you that was embarrassing yourself. I haven't reported anyone. I don't think there is anything more to say. As I said I will be monitoring you from now on.

Didn't realise this guy was involved with Tils.

From the RNS yesterday in the about Tiziana bit

In addition to Milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn’s Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (“mAb”) in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn’s Disease, multiple sclerosis, type-1 diabetes (“T1D”), inflammatory bowel disease (“IBD”), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

The safety test was done on healthy volunteers in the P1. If you look at FDA info on Expanded Access they say it has no bearing on future approvals. It is just about providing access to new and promising drugs without patients in need having to wait while approval ongoing.
Are you definitely talking about approval to start the MS trial in terms of what Dr. Weiner said and not Covid?

With interim data expected in Q4 and expected trial completion in Q4 next year.
Same as for Crohn's

The January presentation says it will be initiated in Q2 this year