Member Info for HotblackDesiato

https://www.australianclinicaltrials.gov.au/anzctr_feed/result?searchText=SDC-1801&purposeOfStudy=&recruitmentStatus=&phase=ðicsApproval=&gender=&healthyVolunteers=&recruitmentSites=&healthConditions=&ageGroup=&recruitmentCountries=Australia&studyType=&conditionCategory=All&conditionCode=&paging=20&page=0

IR has now replied - 'I can confirm that Dr Mitchell attended the recent AngloNordic Life Science Conferece and will be atttending next week’s LSX Congress.'

The e-mail was sent at 16:11 today so the two typos it contains suggest they were either in a rush to get out the office or they don't automatically spell-check....or perhaps both.

Leggster - I'm beginning to feel like a kid waiting for Christmas so what must the Board be like?

Hi Leggster - I think the HREC committee will just respond saying it's all confidential unless you're the sponsor. For punters to attend an ethics meeting, the agenda etc. would have to be made public and I've not been able to find that sort of info.

The thing that really makes me question the accuracy of the AI results you posted is how would it know the location of the HREC meeting and participants' names unless it was published on a publicly available website? It can't be accessing confidential info as the authorities might take a dim view so I'm a bit stumped as to where it pulls the data from.

Evening Leggster - that's the unknown, would the trial be considered low risk?

Chapter 2.1 in the link below says, "Research is 'low risk' where the only foreseeable risk is one of discomfort. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk."

https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018#toc__159

My reason for thinking it might have to be classed as high risk is we'd be getting volunteers to ingest a new drug as opposed to, say, rubbing a pain killing cream into a sore knee etc. So once healthy volunteers are assessed for side effects, trials in psoriasis patients would perhaps be considered low risk.

'Course, you could always just phone that number at midnight (Melbourne is 9hrs ahead) and see who answers!

Hi Leggster - no meeting on 10th at St Vincent's according to https://www.svhm.org.au/ArticleDocuments/1936/HREC%20Submission%20Closing%20Dates%202023.pdf.aspx?embed=y

I'm with Dan Wrangle on this - the names seem almost too obvious e.g. John Smith and a doctor called Jane Doe (in case some are not aware, 'Jane Doe' is the name given to an unidentified female patient in a hospital).

Also couldn't find the owner of phone number (03) 9035 5555 via various searches other than it's a landline in Victoria. Feel free to trawl through the HREC commitees in Victoria - https://www.nhmrc.gov.au/file/18584/download?token=7mQ--PRj

Regards.

Hi Silver - the thing to keep in mind is the BoD will be informed of the HREC response first. The ethics board will not publish the pass/fail on any website. The BoD will have to release an RNS asap after being informed of the outcome to say if it's game-on or not. They can then submit the CTN which should be available to see here https://www.australianclinicaltrials.gov.au/anzctr_feed/form

The ethics review can ask for supplementary info and also ask to interview the lead sponsor if required. I'd imagine they could do the interview via Zoom rather than being in the same room however depending on when the HREC application was sent and when the committee can add us to their agenda, we may not have had our application reviewed yet - it could take up to 3mths from the time of application.

At least we know 1801/737 news is on the horizon.

How many of the buys are due to Leggster's weird AI search result?

Hi Horse - best to ignore anything from Yahoo, MotleyFool or SimplyWallSt as it's the sort of AI generated twaddle that makes an Etch a Sketch look like a supercomputer. If an article written a month ago claims we've got approval then someone should tell the BoD.

We should give a prize to the first academic paper that references the text from your result.

Well this made me laugh - I just tried NeevaAI beta and searched for a section of the text you'd posted, 'Sareum SDC18021 is designed to bind to CD73' just to see if it came back with a source. Well it comes back with 1 source of this text - lse.co.uk. Now that's clever!

I think our computer overlords are toying with us.

10 Kill all humans
20 Goto 10

Evening Leggster - the problem with AI is it's often as stupid as it is clever. If the BoD had applied for a P1 trial using anything other than 1801 then they'd have to put out an RNS.

I just tried https://andisearch.com/ and searched for "Has SDC-1801 been granted ethics approval in Australia?" and the result didn't tell me anything new - effectively just quoting from the SAR website & Edison.

Just out of curiosity, can you let me know which AI search engine you used and what your query terms were?

The SAR events webpage notes the AngloNordic Life Science conference was last week and next week we have the LSX World Congress. Apart from a tweet to say Tim's in Boston in June, it'd be nice to know if we're still actively shmoozing or if perhaps there's not such a need now - cough cough, deal happening, cough, splutter.

I've pinged off an e-mail to our top-flight IR peeps and will report back.

What would make you think that the MHRA is a private company?

Hi Corcs - we have to get through the ethics approval first and that can take between 1 & 3 months so we're certainly within the window of news on that front. Approval would be news worthy so the BoD wouldn't be able to withold that from the market. Once (or if) approved, they would submit the CTN and the benefit of the Australian system is we don't need to wait for anyone's opinion to continue; we'd just notify the authorities that we would be starting a trial and that's that.

So assuming no MHRA-style backlog, we're looking at perhaps mid-June at the latest for ethics approval. The BoD would then send the drugs to Oz and the clinic would recruit healthy people. That shouldn't take too long at all. Perhaps allow 3mths for dosing and looking for signs of anything nasty then we're onto initial trials in patients with psoriasis. I would guess we might hear of those results in Oct/Nov if it's taken the full 3mths to review the ethics application.

I have no idea how the sp would respond at each stage - RMM's post would probably be the most reasonable view to judge things.

Regards.

Only of passing interest but thought it worth a mention:

Biotech deals pick up: Mergers and acquisitions (M&A) in the pharmaceuticals sector have been revived following a slump in activity last year, says Lex in the Financial Times. Bargains are now rare. Firms are paying an average premium of 125% in the seven $1bn-plus deals this year, compared with around 75% in the previous three. As for GSK, it is paying around double for Canada’s Bellus Health, at $2bn. That’s thanks to the spinoff of its consumer division Haleon last year, which freed up £7bn, and GSK now needs to deploy that capital to boost its underwhelming pipeline and close its one-third valuation discount to the wider sector. Bellus’s single asset is camlipixant, a drug for chronic coughs in a market devoid of treatments. It is in late-stage trials and sales could reach $1.1bn by 2028, estimates bank Jefferies. US rival Merck, however, is working on its own treatment, gefapixant, and it, too, is betting big with a $10.8bn takeover of Prometheus Biosciences, despite the Californian biotech having no approved drugs, says Ananya Bhattacharya on Quartz. Prometheus is working on a drug to treat autoimmune conditions that Merck hopes will offset the expiration of the patent in 2028 on its Keytruda cancer drug.

Ohhhh, a bit of subterfuge! Good point, PCS. Who would have thought of Tim as being Head of Covert Operations?

It's always the quiet ones you need to watch out for.

Hi Aber - yup, who knows?! Although there are almost 200 HRECs across Australia, there appears to be one on our doorstep so that's why I'm thinking it's the one at St. Vincent's.

Not sure why they didn't register the company as Sareum Australia right from the start - that's the name I was searching for before we found out it was Pampisford.

Regards.

As we're registered in Melbourne wouldn't it be more likely that we'd apply to the nearest HREC facility rather than one in a different territory?

I posted this link last month - https://www.svhm.org.au/ArticleDocuments/1936/HREC%20Submission%20Closing%20Dates%202023.pdf.aspx?embed=y

I see there is a reply to Robert Zimmerman https://www.whatdotheyknow.com/request/experimental_drug_sra737_2

(Just want to point out Mr. Z is not me.)