Member Info for HotblackDesiato

Hi SOG - if we've been dealing with one of the entities from the list below then it strikes me it's all just a delay due to a bit of red tape and rubber stamping.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1115057/Current_Members_of_the_UK_GLP_Compliance_monitoring_programme_version_9.0.pdf

Just a reminder that it isn't always plain sailing even for big pharma - https://www.lse.co.uk/news/GSK/gsks-oncology-business-suffers-fresh-blow-with-zejula-setback-kpi624y8a6f2n5q.html

"Britain's GSK said on Friday it would limit the use of its ovarian cancer drug Zejula in the United States as a second treatment option to keep cancer at bay in patients whose tumours carry certain mutations.

The news marks a second setback for GSK's oncology portfolio this week, after the company on Monday revealed its blood cancer drug Blenrep failed to outperform an older therapy in a key study, calling into question Blenrep's existing U.S. approval."

At least we've not had an after-hours RNS today which would suggest we're still in the game.

I'd be surprised if they've not been fully appraised of the finer details of the MHRA response and they may even have been kept up to date throughout the last few weeks if there has been any ongoing dialogue between the MHRA & the BoD.

I'm sure if they felt the BoD weren't capable then they would be leaning on them to make changes - "no more funding from us unless 'he' steps down."

Though as others have suggested, the setback may simply be down to this being SAR's first CTA and therefore as an unknown entity it get's the full due diligence from the MHRA.

Hi Gunner - ok, please post the EXACT wording of the MHRA response. This might shed some light on whether or not the issue rests with SAR itself or with one of the labs we dealt with.

Probably best if you copy and paste the entire thing just so there is no ambiguity.

Amazing how people want the BoD's collective head on a spike without knowing all the details.

Shoot first, ask questions later.

Morning Warty - yes, I quite agree that if 50% of CTAs fall short on first submission then there's a good chance of the guidelines being unclear.

Anyway, my point was the review panel didn't have an issue with the science so it's all down to red tape.

As a slight aside, a bloke I used to work with decided to sort out his mother's estate himself rather than use a solicitor. He filled out the relevant forms and took them along with the death certificate to the court in Edinburgh. The bloke there looked through the docs and said, "sorry, it isn't filled out correctly". When asked what was wrong, he informed my colleague he wasn't allowed to say where the error was, just that there was an issue. He went home and reviewed the docs and made a couple of changes. Back to the court - same thing again. After another couple of attempts things got sorted but along the way my colleague discovered that it very much depends on where you live as to what the local courts deem acceptable or not.

Just musing and wondering where the problem lies. You'd expect all the labs that SAR use for pre-clinical trials and the compound manufacturing facility will have accreditation etc. so I'm just wondering if the GLP consider SAR HQ itself to be a lab of sorts and therefore it requires some type of review. Yes, it might just be two blokes in a shed but if they've taken delivery of the capsules then they might need to show they're stored safely etc. etc.

Either way, I'm sure the HNWs have now given the BoD some, uh, 'strong encouragement' to get things moving.

On the bright side, it appears the science is all good and whenever we get round to 1802 then the same mistakes/oversights won't be made.

I wonder if the non-clinical data they're referring to relates to final QC checks as per the recent RNS -

"Synthesis of SDC-1801 drug substance under GMP conditions has been completed successfully, with a surplus of material for the planned Phase 1 clinical trials. GMP-compliant manufacture of capsules of SDC-1801, intended for use in the Phase 1 trial, is also complete, and the capsules are undergoing rigorous quality control checks before delivery to the clinical unit."

"We estimate that approximately 15% of applications fail at the validation step when submitted to MHRA Information Processing Unit (IPU), before ever reaching an assessor."

https://www.gov.uk/government/publications/common-issues-identified-during-clinical-trial-applications/common-issues-validation

As SOG & Brighty have pointed out, we just need to supply the relevant info and off we go...again.

Very true.

As Laz posted the other day, "...I am being reliably informed from a good source that CTA have a significant backlog and are using minor queries as a further reason for delaying applications."

I suppose this counts as a minor query as it isn't an outright rejection.

It perhaps gives them a bit of time before the market opens tomorrow to come up with a plan of sorts - maybe a 7am RNS to say director buys are happening? That might prevent the sp tanking too far.

Well that's the sp trashed. WTF.

Nah, the 9p was due to thoughts of AGILE funding for covid. Those were the days....

Evening Andy - on the assumption the CTA is no longer priced in (was it ever?), I'd hope the sp is well above 1.70 once it's approved!

Many thanks Krone & Aber.

Without being able to scrutinise the contract, does anyone know if it's possible to circumvent the 3mth wait for 737 to be returned and get it handed over now?

I'm sure the CRT/Pioneer Fund are already planning the next steps of development but why wait 'til the end of January if it's just sitting on a shelf? (Unless of course Sierra/GSK deliberately want to delay the competition - I might have answered my own question there.)

Lifted from the notoriously useless Motley Fool site.

To quote Mr. T, "I pity that fool."

Sorry, meant to also add the MHRA encourages CTA applicants to post details of their trials on a publicly accessable database - https://www.isrctn.com/search?q=

No sign of Sareum or SDC-1801 yet :-(

Evening Becks - I've been poking around that website (and other similar sites) for a few months now but still no sign of SDC-1801.

I think the link below might be more useful as it details the drug being trialed etc.

https://clinicaltrials.gov/ct2/results?cond=Healthy&cntry=GB&city=Manchester&Search=Apply&recrs=b&recrs=a&recrs=d&age_v=&gndr=&type=&rslt=&phase=4&phase=0

Hi Laz - if it is just a straightforward delay at the MHRA then you'd have thought Parker could bung out a quick tweet along the lines of, "Our 1801 CTA is still on track but internal delays at MHRA means patience is required."

It wouldn't have to come from the SAR account but it would steady shareholder feelings and indicate the delay hopefully isn't down to questions over funding.