Member Info for HotblackDesiato

Not sure if this has previously been posted but thought I'd add it just in case.

Chinese research with SRA737 - https://pubmed.ncbi.nlm.nih.gov/35887326/

Also the following site may prove useful to know about as a resource https://www.mycancergenome.org/content/drugs/sra737/

Seeing how bullish the BoD were at the AGM regarding our pipeline, they would refuse 250p a share (as would most shareholders).

Taking a wider view of the current situation, we probably have two possibilities for funding:

1. If there is an orderly queue forming at the 737 checkout then it might (only might) lead to a minor bidding war and a healthy upfront milestone payment would help our bank balance.

2. While some here have posted that the HNWIs should (or could) be hoovering up shares on the open market at greatly discounted rates compared to their original buy-in, this perhaps ignores the HNWI's possible intentions as buying on the open market does not directly help the company. Giving funding directly to SAR in exchange for shares and/or direct access to the BoD, helps both parties. Once the CTA is cleared and we know what's happening with 737 then the sp will rebound markedly. The boost in shareholder confidence will perhaps see HNWIs support the company again by taking up their options as and when the time comes.

Also, as was intimated at the AGM, potential partners for 1801 have more or less stated that once P1a data is in, they'll be interested in talking deals. I'd guess if we finally got into clinical trials in, say, Feb, then we might have data by mid-year. Plenty money in the coffers for now to keep us going.

'course, I could be taking cobblers.

Abbas Kazimi: "Humbling to see the headlines about ‘the largest upfront fee ($4B) ever paid for a single, unapproved drug’"

SAR: "Meh, you ain't seen nothin' yet, baby"

(Cue replies from our resident doomsters)

I'm afraid it doesn't work like that. If the MHRA wants proof of something then they'll want to see the actual computer record & electronic signature (or equivalent) of whoever signed off the trial methodology etc. to ensure it met GLP requirements.

More info here: https://www.gov.uk/guidance/good-laboratory-practice-glp-for-safety-tests-on-chemicals#glp-monitoring-inspections

Although I can't find a website detailing the results of any GLP audit, I imagine it'll be similar to this one for Medicines and Healthcare products: https://cms.mhra.gov.uk/mhra/gmp?f%5B0%5D=gmp_country%3AGB

The first entry from the above M&H list is https://cms.mhra.gov.uk/mhra/gmp/uk-miaimp-48101-insp-imp-4810116778860-0005i

I've no doubt the records for our lab work will exist but it'll take time for the authorities to get their act together hence it may be quicker to go abroad.

Hi Lucan - from what I recall from this morning, it sounds like the MHRA accept the actual numbers (whatever they may be!) but want evidence the lab applied the correct procedural process during the tests. The BoD were very bullish in their response; they know the lab was licensed at the time to carry out the work and they are adamant that 1801 will go into clinical trials. With the MHRA dragging their heels, it may prove a better idea to change tack and run the P1a trial outside the UK.

The query relates to how certain figures were arrived at by the lab carrying out the work for us. They haven't questioned the numbers themselves, just the process. As the BoD pointed out, the lab has the paperwork to show they were fully licensed at the time so it sounds like it's just a case of a jobsworth at the MHRA.

Hi PCS - re the person you suspect might have been one of the HNWs, by any chance was it the person with the foreign accent? Sounded a bit Belgian to me...

Hi SOG - assuming I heard the AGM Q&A correctly, when the data gets handed back in Jan, the SO combo patent application will also transfer across rather than it being nullified.

Can you confirm if that's also your understanding?

Hi Baton - and now on the share riser's board so hopefully that'll put an end to the doomsters!

So the BoD aren't sitting about twiddling their thumbs and there is a queue of people wanting 737. What's not to like?

Naysayers might benefit from this - https://www.isrctn.com/ISRCTN15676570?q=&filters=&sort=&offset=12&totalResults=22895&page=2&pageSize=10

Morning Warty - what we don't know is if the info required by the MHRA is because it was missed off the CTA or if the CTA itself was 100% complete but the MHRA are at liberty to ask supplemental questions.

I've submitted a question to the AGM along the lines of, should the required info have been included on the CTA and if so, what circumstances led to it being omitted? Once we know the answer to that we can start pointing fingers.

No sense attacking the BoD if the CTA didn't require the info at the time of submission. If it turns out that the lab we used fiddled data or whatever then surely they must pay compensation etc.

Lucan - perhaps the BoD have already been able to gather the supporting info required by the MHRA and are awaiting the final decision. Therefore you could add a 9th point to your list, 'on the other hand the CTA could be granted on Monday.'

Hi Warty - give your broker a call and they should be able to help. I've previously voted just by calling Halifax and asking them to note my choice of x or y.

Hi Potnak - no idea if punters can go along to PH HQ, isn't it just by video link?

Anyway, I guess there are two possibilities; either by holding it at PH they can more easily hold off the pitchforks & burning torches or they are there to also ink a partnership deal (pending CTA clearance). At this stage it could go either way!

Let's see how long it takes for the doomsters to poo-poo the notion of any partnership deal.

Evening Celtic - just a couple of points to hopefully lift your spirits (and I'm as cheesed off with the current sp as everyone else - now underwater on both my investments!)

I don't think we'll have any problem seeing eventual success from 737. I responded to one of SOG's earlier threads with a 737-related link. Part of the abstract states, "... Uniquely, we show CCT245737 enhanced gemcitabine antitumor activity to a greater degree than for higher doses of either agent alone, without increasing toxicity, indicating a true therapeutic advantage for this combination." Still a long way to go but there must be takers awaiting access to 737.

Regarding the CTA, it's very easy to blame the BoD for the current situation we're in but we simply do not know if it's due to the BoD omitting key evidence from the application or if it is at the MHRA's discretion to ask for supplemental information when reviewing a CTA. Yes, the RNS was poorly worded (bit of an understatement), but that doesn't mean the BoD dropped the ball on the CTA. Until we have clarity then we just have to grin and bear it.

Warthog was trying to get in touch with our new investor relations person and I posted a link to her phone number. While it's fun to grumble on a forum, anyone here can call her to, umm, 'clarify current shareholder sentiment' and perhaps provoke an official response. If Alex takes her job of investor relations seriously then she may peruse forums to get a feel for 'the word on the street'. Certainly if I were in her position, I would - oi, Alex, are you reading this?!?

Anyhoo, I know fek-all about football but I gather Wales are about to thrash England so I might tune in to that for a bit.

Regards.

Hi SOG - I'm sure you'll have come across the site below but thought I'd post it here for others. Quite reassuring to scroll down through the citations section and see entries with Oct/Nov 2022 dates, suggesting 737 has not been forgotten about.

(note of caution - you'll need a medical degree of some sort to fully understand things but even a determined amateur will hopefully get the gist.)

https://www.researchgate.net/publication/281137860_The_clinical_development_candidate_CCT245737_is_an_orally_active_CHK1_inhibitor_with_preclinical_activity_in_RAS_mutant_NSCLC_and_E-MYC_driven_B-cell_lymphoma

Hi Warty - perhaps you got trapped by her spam filter (it does happen) so try phoning her instead: https://consilium-comms.com/our-team/europe/alex-harrison/

https://www.fiercebiotech.com/biotech/abbvie-links-london-vc-firm-map-out-new-anti-inflammatory-companies

C'mon, SAR, let's get 1801 front and centre.

Hi Luton - last night I took a wee look at other company BBs to see what was being said and, surprise, surprise, they too had infestations of people belittling others, posting lies, name calling etc.

Ahhh, makes you proud to be human.

Due to the MHRA's internal delays, I wonder if they've relaxed their 14-day window for responding to any concerns re CTA applications. If so, then that will play into our hands as it clearly gives more time to compile whatever info they need. However if they've rigidly stuck to the 14 days (and if we haven't been granted an extention), then we should have had some sort of RNS by now to announce either we have or haven't been able to supply the required info - y'know, keep the market updated and all that jazz.

In previous meetings the BoD have indicated that lessons learned from the development of 1801 could apply to 1802 in order to streamline its progress. I wonder if we'll see some sort of 737 deal in the new year where upfront milestones rather than a raise will be used to accelerate 1802.

I've submitted a few questions for the AGM -

1. Was the MHRA's concerns regarding Good Laboratory Practice an unforeseen query or should the required information have been included as part of the application? If the evidence required by the MHRA should have formed part of the application, what circumstances led to its omission?

2. What lessons have been learned from SDC-1801's development and subject to any required funding, how can they be applied to accelerate or streamline SDC-1802's progress?

3. With the imminent return of SRA737, have you been able to make any concrete plans to progress it or do you need to wait for it to be 'officially' returned (and to review any associated data) before working on the next steps?