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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.
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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.
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.
Recent Investor meet question and answer...
Q24: Do you have dialogue with the current investors?
We are in constant dialogue with our investors and we are glad we have supportive and engaged investors.
Investors will undoubtedly put the positive spin on the return of SRA737, as previously mentioned we now have a phase 2 drug ready to license with some profound results in SCLC.
It's a bumpy road to market sometimes as those who know about Momoly are aware, majors don't always get it right.
It will be interesting to see what Stephen and Tim know about the return at the next investor presentation which should be in the next 2 weeks.
The fact that none of NEDs have left the company shows we have something worth sticking around for.
https://quoteddata.com/2019/04/sareum-notes-strong-preclinical-sclc-data-sra737-aacr/?amp=1
Complete tumor regression of small cell lung cancer in combination therapy.
Having this back on our books is not a bad thing. Yet it certainly doesn't make sense that GSK aren't wanting this, big pharma don't want to cure afterall, more money in ineffective treatment for years.