Member Info for Num4

Hi Andy, I'm good mate, looking forward to the next few months as Sareum have a real opportunity to manage the SP in the interest of shareholders.
Although part 4 doesn't have a PASI score as a primary outcome they are requiring participants to "4. Has moderate to severe plaque psoriasis at baseline as defined by a PASI score greater than or equal to 10 and a PGA score greater than or equal to 3 at Screening and Day -1."

It feels they have really set themselves up for success, they have the ability to report on primary and secondary outcomes at each stage of the trail, of which we have 4, 2 and 3 can run concurrently so we should expect a healthy stream of positive news from any day now, until next year.

So many string to the bow and we are really looking like a clinical stage company now. Except the number of personnel and overheads. Which makes a full buyout extremely efficient. One something is agreed I don't expect it to take long to filter through the company, of 3.

I'm sure Australia would also jump on the covid-19 application of SDC-1801 once proven safe.

Looking forward to seeing these big daily increases again.

Just reigniting this thread. A more important and final trial is also available to view with some interesting insights which may tell you the thought process of the board:
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385667&isReview=true

"Part 4 of this study will have a randomised, double-blind design, and consist of 2 sequential dose cohorts (Cohorts Psoriasis Dose i and Psoriasis Dose ii). Each cohort will consist of 12 participants with moderate to severe plaque psoriasis."

Yes, 12 participants in each cohort.

"Each participant will be in the study for approximately 8 weeks (Screening Visit to Follow-up Visit) and will receive a maximum of 14 or 27 doses of SDC-1801 or placebo."

Either we don't have enough money to run a larger trial or we don't really need to due to expected license already pre-agreed based on parts 1/2/3 being a success.
I don't think we would take on such a low amount of participants based on lack of funds, the company has come this far and in my opinion if they thought they needed 50/60 participants to get this over the line then I am confident that is the route they would have taken. Having only 12 in each cohort for 8 weeks shows a level of confidence for the future of the compound imo. Perhaps they won't even get that far and once safety data confirmed and it moves through parts 1-3, the license comes with a larger phase I/II by someone else.

Great find HBD. Hopefully we made the timeline for HREC in April.
Doesn't seem like they have used the previously mentioned phase 1a and b. More phase 1. Then split to 2 parts. As it also states it wants psoriasis patients.

This is when I believe we will see further high net worth investors provide the funding, when it's in clinic the next stage for us is a buyout / license. Sooner you get in the better, HNW will be happy with the current share price and I suspect further millions coming our way as they take positions to support this compound. They know the end potential now, $4 billion at phase 2, Nimbus. Got to be back up to 400milliom market cap in the next month or 2.
GLA.

Not spoke to him since last June. I can still phone his WhatsApp and messages go through, but not read.

Yes seen that. I would encourage Stephen Parker to reach out to his MP with the reality. Big R&D boost also. Importantly for those long term investors, lifetime allowance scrapped. Happy days.

No doubt out existing investors are speaking to Tim and Stephen about this progress and the level of assurance they can provide with approval of these trials in Australia.
As mentioned refusal again would destroy us, but John gave a very confident statement at AGM that we will not have the same problem as we had with MHRA.

It's an absolute disaster for the UK though, from being ready to go at Manchester to now transfering to Australia. Does this mean we are a multinational now, having an entity in Oz. Haha.

And it's stories like this that Sierra Oncology should be taken to a form of Medical ethics council, as well as the CRT Pioneer Fund for not applying enough pressure. A criminal offence in lots of peoples eyes letting this sit and gather dust. Best wishes to you potnak and your family.

You should get your update before end of Feb, half year results due. Pharma is a new level of slow, as most of us are aware now. The hare, tortoise and Sareum.

Hopefully it's the inside seller now becoming the buyer. News tomorrow.

Indeed - Let's hope they give it back in good order with full genetics report that John was referring to. Instead of a pile of paperwork with post-it's and coffee strains on.

Statement of the year from Sareum, by Stephen Parker. "form an orderly queue" in relation to SRA737 on license.
We need to change the name soon as it comes back. SAR737!

Thanks to the attendees yesterday. Delay with MHRA is exactly that, a delay. Very interesting that we are now going to EU and outside EU. EU trial regulation is surpringly favourable for us as you apply once to several countries instead of individually.
"
Prior to the Regulation, clinical trial sponsors had to submit clinical trial applications separately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial.

The Regulation enables sponsors to submit one online application via a single online platform known as the Clinical Trials Information System (CTIS) for approval to run a clinical trial in several European countries, making it more efficient to carry out such multinational trials.
"https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation

I've emailed Tim and Stephen to confirm if we are applying under new EUCTR. As mentioned with that route we will have to get some patient documents translated but not a hardship.

It's positive that they are not just standing still on this.

The business model is sound and the 120 person phase 1b is more than sufficient to prove safety and efficacy for a hefty license deal on the back of it.

Still holding and here until the end game.

Your not going to get a clearer comparison for the worth of what we have. When this is approved for P1a then we are off, look what Sareum now have for a comparison to get investors interested.
Could be a blue week moving forward.

The biggest concern and potential setback, not failure but setback is that they have requested further animal studies. That is the worst case realistic scenario here IMO.
The fact that we haven't been told that is a good think, as Sareum would have to tell us this immediately as it will take a number of months and unexpected costs to do another animal study.
Since they have not told us that in 5 weeks since the delay, we can only hope it is something more trivial.
Perhaps Sareum just need to take the MHRA assessor out for his Christmas party.

I normally try and post when the price is down, but It's difficult to defend the company at the moment.
Only thing I would say is that Tim and moreso John have successfully registered multiple patents over many years, they know how to be compliant and they don't take shortcuts.
Whatever the issue may be I suspect it will damage the feeling towards MHRA rather than Sareum on the board - when/if it ever comes out.

A good few years ago now, our chairman updated our governance framework to bring us up to date with AIM regulations so I'd hope that they have the finger on the pulse when it comes to 3rd party assurance. We've been comfortable with the CROs for years and as a result of their work we've been published and cited in medical journals.
I hope Stephen and the NEDs are all making the relevant enquiries and a positive update to the market it coming. Looking forward to hearing more detail from the AGM on this major issue in our development.

It wouldn't take that much of an investment from the HNWI'S to take a controlling stake in the business, how much do they believe in 1801 though as they won't throw good money away. According to Tim they have supportive and engaged investors.
This will certainly be putting that to the test.
It is quite incomprehensible that an admin error has paused this, consultants ontop of Tim and John, on top of our NEDs who must have had some insight aswell. It won't be doing any of them any good.
This needs mopped up quickly, and a suspension might not be off the table due to the large sells showing a breach in integrity and reputation of the market.

Them large sells just show that we aren't leak tight. Suspend the shares so they can't buy back in until we have the admin sorted on the CTA.
Tim won't be sleeping tonight that's for sure.

Consultants failed here, poor show.

SRA737 return is a classic example of why drugs take so long to get to market. Priorities change quickly.
For the foreseeable tyk2 is now in the spotlight, why Psoriasis... Because we can now show that 2 guys have developed something to go head to head with a BMS drug. Huge market and once we are in the clinic we'll be included in all them future competitors analysis.
Evidence suggests that dual inhibition can give greater efficacy, this is well known in the space so it certainly gives BMS something to think about.
Hoping to get into the clinic this week. Good luck all.