Medicines and Healthcare Products Regulatory Agency

And what do you think we should be concerned about though when it comes to the use of AI in general practice?

We worked to try and get the best out of the MHRA commission into regulation of AI.

So we fed into that quite a lot because governance is absolutely key.

We make sure that it is safe.

Will it change how we think? Will it make us dumber? I think there's a high chance of both of those.

And what role do you see the college playing in supporting the rollout of AI in general practice safely and effectively? Because obviously the college will have a role in this, won't they? The high standards are what you're all about.

Yeah, so we have been trying to get the governance right through the MHRA.

We've also been in conversation with NICE, who have a role in terms of what they approve.

Our autumn interview specials continue, but just a quick recap on what you've missed.

So Jeremy Hunt, Longest Serving Health Secretary, Head of the MHRA, Lawrence Talon, Kim Ledbetter MP about life and death, Dr. Zan Van Tullican about the wellness industry in his new book, and last week, Professor Peter Fonagy talking about his independent review into ADHD, autism and mental health conditions, which...

I can tell you is already our fastest downloaded episode.

So there's a lot of interest in what Peter did.

The trial is currently being run in the UK But since Brexit and through discussions that we've had at a board level, we have recognised and decided that we need to add EU data through EU participants in that trial.

And one of the reasons that we decided and wanted, one of the core first steps to doing that was to re-examine the data in the phase two trial through the endpoint that the regulators require or expect both in the UK and also now in the EU since Brexit, the separation of EMA into the MHRA and into EMA.

When we re-examined the phase two data using that endpoint of reduction in heavy drinking days, the results were, in our opinion, strong.

We achieved a 55% reduction in heavy drinking days in the active arm of the trial versus the placebo arm of the trial across the final two months post-treatment in months four and five post-treatment, so out to the six-month window.

So Anthony, why does bringing European patients into the trial matter for SVN001, and how does a short course of treatment compare with new approaches such as DLP1-based drugs like Pervititude, Dutite, and that are taken continuously?

Yeah, so we as a board want to progress this program through to the end of phase three and then seek to launch it ourselves in the UK and in the EU.

Since Brexit and the separation of EMA into MHRA for the UK and EMA for Europe, we believe we will increase the probability of that outcome by having EU citizens in the trial.

And in order to do that, we are now seeking to expand the trial or to add EU sites to the trial to give us that EU data in the trial.

And with AI we need clearer arrangements for regulation, accountability and ongoing monitoring.

And I know MHRA has started that work and we are working with them.

GPs need to understand what these tools can and cannot do and remain able to exercise independent clinical judgment.

This is really, really important.

And so before being appointed as chief executive officer, I was serving as chief operating officer.

And that was during the time that we were very fortunate to receive our MHRA certification here in the UK for both critical starting material and drug substance.

And then ultimately appointed a CEO earlier this year.

So my job is... very different i think every day um i would say i'm quite an operational ceo still i'm very very lucky to have an amazing team and a new ceo beneath me but i love the science and i won't ever be too far from the science but of course um sitting in this chair also involves investor relations corporate development and all of those um all of those relationships so it's yeah i'm really lucky

And so we're actively pushing on that.

We have a drug master file filed with the FDA.

We've had a number of interactions with both the FDA, with EMA, and of course the MHRA.

And I think we're starting to break that down.

But it was when we realized that the cancers were nearly all associated with the new messenger RNA ones.

Indeed, the messenger RNA ones are universally the only ones used in this country for the boosters, because AstraZeneca, realizing the extreme damage caused by their vaccine in clots and strokes, and with 48,000 yellow cards sitting on the MHRA that they do absolutely nothing about.

realized that there would be reputational damage so they withdrew it they didn't wait for it to be banned which they should have banned ages ago the regulatory authority the mhra failed abysmally in controlling this but that's something we could go back to but with regards to the cancer we suddenly realized it was the messenger rna and then these people who's had some very aggressive cancers The surgeons had sent the tumor off to have a look at what was actually in the tumor.

And from America and Europe, they found that they had the spike protein actually inserted in the cancer.

And yet they're wanting me to have them every six months.

I can only conclude that the government really wants rid of us all because we're a drain on this economy.

Rather than fix it at the beginning, they think, well, we'll get as many people to fall off the cliff while while we can to reduce the amount of money we've got to pay and you know that that is not as far-fetched as i thought as i said 2019 i would said you're mad to even think that after what we have gone through And all the warnings we've given, and I can't tell you how many people, you know lots of the people involved that have been doing this, we've been screaming, we've been writing to the rotating number of Minister of Health, so Prime Ministers, MHRA, Department of Health, and some of these things are so important, we have 150 signatures of really senior doctors and physicians, they don't even reply.

They don't even reply when we're warning them of this stuff.