Member Info for HotblackDesiato

From the Businesswire article -

Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19.

So taking Sotyktu could lead to respiratory issues that 1801 might be a key treatment for! As the CTA RNS stated, "The Phase 1a part of the trial is expected to provide safety and dosing information applicable for any future trials in patients with other autoimmune diseases and the acute respiratory symptoms of viral infections, including COVID-19, should the Company decide to progress such trials."

It's crazy to think that 1801 might be one hell of a silver bullet. Still years away from market but, jeez, what an amazing compound it might turn out to be.

No doubt we'll still get a few doomsters posting but the potential for huge deals cannot be too far away - I'm still thinking once we get P1a results then we're off and running.

More on this via Kendyboy's earlier post today - https://www.businesswire.com/news/home/20220817005643/en/%C2%A0%C2%A0U.S.-Food-and-Drug-Administration-Approves-Sotyktu

If the BoD/Consilium/PH want to capitalise on this news then I think they'll have to push the, "With SDC-1801, we believe we are entering this space with a strong candidate that exhibits potentially best-in-class features" angle.

Hat's off to Kendyboy.

Hi Bailiff,

Not sure there is a definitive answer but would hope there's an associated RNS.

However see quote from the link below re commercial sensitivity -

https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/phase-1-clinical-trials/

"From 1 January 2022, trials submitted through combined review will be automatically registered on ISRCTN Registry when given full approval.

We recognise that commercial sensitivity may be a concern in some sectors, including in Phase 1 trials. It is possible for applicants and sponsors to request a deferral of registration on a publicly accessible database."

I'm also keeping an eye on a few websites just in case there's no RNS -

https://www.clinicaltrialsregister.eu/ctr-search/search

https://bepartofresearch.nihr.ac.uk/results/search-results?query=psoriasis&location=Manchester

Have you managed to complete your recent buying spree?

An interesting find, Krone, though not sure if 737 (or whatever they might now call it) would get a mention just yet as it isn't 'officially' on their pipeline list. Might still have to wait 'til end of Oct. :-(

Mind you, WIP did mention he'd bought another £10k so things must be happening behind the scenes.

Not sure if a specific trading statement is a legal requirement or not. The end of July RNS probably covered everything as it included a corporate update so perhaps no need for a specific trading statement.

Utah - on the 19th Aug. you said you'd bought another 1200 shares. Quite a radical strategy for someone who doesn't seem to have much faith in the company.

As for your grumble about what some posters expect/hope will happen, you do realise this is an anonymous internet forum and nothing that gets written, or rather, predicted, should be the basis for your own expectations. You're an adult, learn to make your own judgements and if you feel some posters give false hope too often, filter them. It might cheer you up.

Good grief, Krone, can't you see they've been rushed off their feet compiling pointless lists?

https://consilium-comms.com/news-insights/consilium-conscience/consilium-conscience/2022/consilium-summer-play-lists-2022/

Morning BenH - this should help explain why each phase takes as long as they do.

https://en.wikipedia.org/wiki/Phases_of_clinical_research

Just a bit more info:

Phase 1 application process
1. Complete your combined REC and MHRA application
2. Book your REC meeting. For Phase 1 applications, either book your REC meeting using the online booking tool in IRAS at the point of submission or reserve a meeting slot in advance by emailing your chosen REC. REC details can be found on this page
3. Submit your application. Many RECs will accept the submission of Phase 1 applications up to 7 days before the REC meeting date - this must be confirmed before submission. Please discuss this option with your chosen REC when reserving a REC meeting slot. Day 0 is the day the application is received, except where you choose a REC meeting that is not the first available slot when you submit your application. In this scenario, day 0 is 14 days before the REC meeting date. For applications submitted 7 days before the REC meeting, day 0 is the date of submission.
4. REC Meeting and MHRA assessment. The MHRA aims to complete the initial assessment within 14 days of receipt, however the combined assessment is issued together once both MHRA and REC assessments are completed. This ensures reviews are co-ordinated and a consolidated initial outcome is agreed between the two regulators.
5. Consolidated initial outcome. The co-ordinated initial outcome from the MHRA and REC will be issued together within seven days of the REC meeting
6. Response to any Requests for Further Information (RFI) requested by the MHRA and/or REC. You are expected to respond to all RFIs within 14 days. If you need more time, you can request an extension before the response deadline via clintrialhelpline@mhra.gov.uk
7. Final outcome. The aim is for the combined final outcome to be issued within 10 days following receipt of the RFI response.

I'd certainly hope we get an RNS at some point to say the CTA is all good and the trial will start shortly but I've just come across this regarding the notification of trials via publicly accessable databases -

https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/phase-1-clinical-trials/

Just below the application process graphic, it says, "Registration of clinical trials in a publicly accessible database is a condition of the favourable opinion from a Research Ethics Committee (REC). We also publish a summary of research reviewed by RECs in the UK.

From 1 January 2022, trials submitted through combined review will be automatically registered on ISRCTN Registry when given full approval.

We recognise that commercial sensitivity may be a concern in some sectors, including in Phase 1 trials. It is possible for applicants and sponsors to request a deferral of registration on a publicly accessible database."

So much for me scouring various trial databases then.

Thanks for the info, Bobbler.

I'm sure you can understand my confusion when the front page of the WO application states, "unless otherwise indicated, for every kind of national protection available" before then listing all the various country codes.

However I've now found this to supplement your reply, 'Patent Cooperation Treaty (PCT) is an international convention that facilitates a single window application process for multiple countries through World Intellectual Property Organisation (WIPO). This filing helps to obtain registration in the designated countries. It does not create global or world patents, but provides protection only in those countries where it is applied and granted.'

Patent lawyers must get paid a fortune.

Hi Basser,

If 1801 can be used like AbbVie's Humira to treat more than just psoriasis then the eventual licensee/owner could be looking at even greater revenues per year.

Last year Humira had sales of $20.6bn in the US alone - https://www.statista.com/statistics/318206/revenue-of-humira/

However it looks like AbbVie have laid quite a spectacular minefield of 132 patents covering Humira - https://www.reuters.com/legal/litigation/abbvie-wins-appeal-antitrust-case-over-humira-patent-thicket-2022-08-02/

I'd started another thread wondering why a single global patent isn't enough, I think we now have an answer.

Just poking about and I see there is a recent publish date of 25/8/22 for the crystalline forms of a TYK2 inhibitor patent covering Australia.

https://worldwide.espacenet.com/publicationDetails/originalDocument?FT=D&date=20220825&DB=EPODOC&locale=en_EP&CC=AU&NR=2021253128A1&KC=A1&ND=8

Any idea why specific territories get added in this way when the worldwide patent was published last Oct.? You'd think the clue would be the word 'worldwide'!

https://worldwide.espacenet.com/publicationDetails/originalDocument?FT=D&date=20211014&DB=EPODOC&locale=en_EP&CC=WO&NR=2021204762A1&KC=A1&ND=4#

solely, even (rolls eyes).

Hi SOG, thanks for the reply.

This is the quandary that shareholders face - taking the conservative figures you cite, if 737 proved to be a potential blockbuster and is effective in multiple indications, how likely would the BoD be to recommend accepting £75m?

We could do a lot with that sort of cash but if 737 becomes highly desirable, then retaining it as part of our window display alongside 1801/2 would maximise any potential takeover offer. Might it be better therefore to see if our HNW chums could provide additional backing to get 1802 through trials before we sell assets to generate the required funding?

Anyway, I better use the word hypothetically here just in case some think we're being too serious!

Hi Warty, I tried getting real once but had difficulty remembering the 'safe word', but that's another story.

Anyway, if anyone would take £3.67 per share for the whole company then they clearly forget we nudged £4.50 (9p old money) a while back, albeit based on thoughts of Covid success.

As many repeatedly pointed out at the time, Covid is/was a side play.

Some people are glass half full, some are glass half empty and some are 'FFS, the glass is cracked'.

Morning Blue, although we didn't have a seat at the original negotiating table, we are entitled to revenue (eventually) in milestones/royalties and presumably that entitlement can be sold to another party. Surely that element is ours to sell if we choose to and therefore wouldn't it then be a direct negotiation between ourselves and the buyer?

Can anyone out there confirm my presumption?

Just pulling a figure out of thin air, what if GSK offered us £250m+ for our share of 737, would that get 1801/2 through P1a/b trials without needing additional funding AND perhaps even give us a small dividend?

Without a buy-out, it could still be a very long time before shareholders see the huge returns we're hoping for.

Patience is a harsh mistress (insert joke here!)

Very true, Fearg, but we do have some large 'what ifs' to deal with -

1. Though the CTA might be approved next week, CTAs can often be delayed as the applicant has missed some critical piece of info - https://www.gov.uk/government/publications/common-issues-identified-during-clinical-trial-applications

As professional as the BoD are, the fact that the MHRA has had to produce the various docs in the above link suggests even the smartest people can still muck things up when completing forms. Surely we'd get an expert eye to go over it first to confirm it's as complete as possible. Can you imagine what any news of a self-inflicted delay would do to the sp? The MMs would have a field day.

2. GSK will have been looking into 737 for some time but what if it doesn't appear in their pipeline at the end of Oct? On the other hand, what if they made an offer to buy our stake in it?

3. Regarding a deal for 1801, at this stage of development would you rather we sell it outright or license it?

4. Assuming 1801 gets through P1a unscathed, are we then likely to see the HNWs stump up more funds to get 1802 to the same stage? Quite possible as 1802 is a similar molecule and therefore some aspects of 1801's progress may have a 'derisking' effect on 1802.

There's still everything to play for and even if just one compound pays off then I think we're still looking at a £1bn company.

Hi Fearg, I think there are few sellers as many are waiting for the imminent confirmation that the CTA is approved. Assuming it's all good, the sp should move north quite sharply and that will produce a number of sells as a result of people taking profit. They may expect the sp to then drift back as we await the next bit of news - prerhaps 737 being added to GSK's pipeline.

Depending on when the CTA was submitted, we might get the RNS on Tuesday (Monday being a bank hol).

The CTA Submission website states, "Once the application is sent to the MHRA, it will be acknowledged with an accompanying note to say that the trial may go ahead after 14 days from receipt of notification if no objections have been raised. The acknowledgement letter will act as the authorisation.

For Type B and C trials, the notification scheme is not applicable and each application will be fully assessed by the MHRA. They will provide an initial response within 30 days of receipt of a valid application, with an average of 14 days for Phase 1 healthy volunteer studies. The MHRA CTA Page lists the documents required for a valid application."

Info on what constitutes a Type A, B or C trial can be found here (pages 3 & 4): https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/343677/Risk-adapted_approaches_to_the_management_of_clinical_trials_of_investigational_medicinal_products.pdf