Member Info for Silverfoil13

Hi Warthog glad you got support from Andrew with the local issues you had; I guess they get bombarded with these things it must be difficult to filter the most important ones.

Thanks Crogy well done for getting a response from your MP .. I have chased mine up and will post if I get a response! Not confident because frankly I don’t rate Andrew Griffith our MP and my confidence in him dropped further when I saw him standing snuggly alongside Jeremy Hunt as part of the Treasury team that presented that appalling budget for growth (they missed out the word negative from “negative growth”!) last week.

Thanks MaM .. helpful explanation

Are charts really relevant where a company is not trading? The price driver hear is surely news not heads and shoulders. Happy to be corrected!

Company adds that further clarity requested by Sareum from the UK Medicines & Healthcare Products Regulatory Authority regarding its original clinical trial authorisation application has not been received. Consequently, company decides to transfer the clinical trial to Australia to progress the development of SDC-1801.

Preclinical development activities required for the application have been successfully concluded. Synthesis of SDC-1801 drug substance under Good Manufacturing Practice conditions has also been completed successfully. GMP-compliant manufacture of capsules of SDC-1801, for use in the phase one trial, is also complete.

Makes you wonder WTF the MHRA are doing .. or not doing! No wonder AZ and GKN are fed up with them too!

This was the key bit in the budget…

“From 2024, MHRA will move to a different model which will allow rapid, often near automatic sign-off for medicines and technologies already approved by trusted regulators in other parts of the world such as the United States, Europe or Japan.

At the same time from next year they will set up a swift new approval process for the most cutting-edge medicines and devices to ensure the UK becomes a global centre for their development.

And with an extra £10m of funding over the next two years they will put in place the quickest, simplest, regulatory approval in the world for companies seeking rapid market access.”

This sounds very encouraging for the future especially if the Australian CTN goes well!

Is achieving CTN more significant and important than achieving CTA .. is it a higher bar? Excuse my ignorance!!

Thanks Warthog ..

Go ahead MattyBoy!
Thanks for feedback Scheckler. We have managed to get a lot of press coverage both locally and nationally; hasn’t gone to planning yet. We have adopted what I call a “Walls of Jericho” approach attacking the council from all angles hoping that eventually something will give! Fingers crossed they will eventually bow to local public opinion.

Thanks Scheckler appreciate your comments and sense you might be based down this way and that you probably understand how local councils operate; to be honest most people in our town myself included have been completely baffled by the attitude of the local council but I don’t want to bore other BB posters with a local issue. We have solicitors lined up to fight planning when it goes in but the council could have avoided this by listening to the unanimous objections of the whole community to their bonkers and highly risky scheme, accepting that their financial projections were woefully inaccurate and withdrawing the scheme. With local elections coming up there are going to be alot of changes of councillors and the Conservative majority on the council will almost certainly disappear!

Small world eh Warthog! I’ve been trying to get him involved in a dispute we have with the local district council who want to build a 4 bedroom luxury BnB in our conservation area! A pointless and highly risky development that no one wants! Sadly he has said he doesn’t want to get involved which has not helped his popularity!!

His seat may not be that safe unless the government sorts its act out! He’s a fairly recent new MP and I wouldn’t say people locally warm to him! He strikes me as being a bit smug but he is close to the Chancellor so worth a punt!

Letter to my MP Andrew Griffiths. Koolkat may not agree with my sentiments. How can we know of SAR presented a strong case if MHRA have not clarified what they want for over 4 months ?

My letter

Hi

I have been invested in a small biotechnology company called Sareum that is developing next generation treatments for cancer and autoimmune diseases. I have held a significant investment in the exciting products this company is developing for 12 years.

Today the company announced that they had been forced to set up an entity in Australia in order to be able to initiate and progress clinical trials on their lead product 1801 which offers therapeutics for a range of autoimmune diseases. The Company has been forced to do this because the MHRA (UK Medicines and Healthcare Regulatory Agency) have been unable to provide any further clarification to Sareum whatsoever subsequent to the MHRA's decision on 8th November to delay approval for clinical study and testing and request further information and review in order to approve of 1801. The MHRA advised Sareum in November that they required further information but in spite of requests from Sareum for details of what extra information is required the company has heard absolutely nothing.

Astra Zeneca and Glaxo have already expressed grave concerns and exasperation with the delays in processing approvals at MHRA and this episode with Sareum is just one more example of the utter ineptitude of the MHRA. Sareum, like other biopharma companies, are working tirelessly on vital research on life saving and life enhancing treatments and it as an absolute disgrace that this work is being hindered and delayed by the complete incompetence of a government agency.

I could barely believe my ears when the Chancellor referred to MHRA as one of the most respected health agencies in the world; does he have any idea what is actually happening on the ground and in the real world. It's frankly embarrassing. He proudly proclaimed the UK as a life science super power but how on earth can he make that ludicrous claim when the UK's main drug approval agency takes more than 4 months (and still waiting) to clarify what information it needs in order to approve a potential new treatment for clinical testing?

The Chancellor promised to speed up drug approvals by 2024 to achieve world leading status well it seems he has an awful lot of work to do to get this particular house in order.

In the meantime Australia, with their more efficient and streamlined clinical testing procedures, are likely to steal another potentially significant drug development away from the UK meaning more lost credibility and income for the UK. Not only is the UK, via MHRA, missing out on commercial trial activity but it is delaying vital regulatory approval of ground breaking and life changing drugs because of sheer incompetence.

The sooner this is resolved the better for the UK and for patients.

Chancellor has just said how proud he is of MHRA which the most respected agency in world. Proof if ever needed that politicians live in a deluded world! Good news however was that he committed to speeding up approvals by 2024!

Came across these people this morning who seem to raise issues like this; they have highlighted similar issues that GSK and Astra have has with clinical testing. I will contact them too.

Great find Jocko many thanks!

RAB Capital there’s a blast from the past!!

Thanks Fin .. the possible time scales are interesting!
I think development progress at RKH would trigger significant price rises in RKH and BOR; I need 40p on RKH to breakeven but from current price of 12p would be very happy with £1 which is quite possible once Navitas and FOG press the “go” button which could easily be in 2023!
I try to keep 90% of my portfolio in safe stuff (cash and high yielding investment trusts) and 10% in high risk fun stuff. As well as the oilies I have GGP, ARV, GFM, CDL and POLY. I also have a stake in a little pharma company SAR!! Keeping an eye on these at least helps make the days interesting. I am 68 next month and so really want to see some action on some of these in next 2 years whilst I’m still allowed to travel (car hire and travel insurance start to get tricky!!)

Agree Potnak it is time and “mental energy” sapping waiting for news on 737 and 1801. Although I have been waiting here for over 12 years, and got all my original money back and more when I sold 1/3 back in 2021 I feel increasingly impatient not helped by the unrelenting march of time as I approach 70! I’d like to enjoy some of the fruits of 12 years of patience and even half a billion (old 14p) at some point this year would see me happy (relatively)!

Interested to see Fin has gone big into RKH and ZPHR.
I’m into RKH, BOR, Predator, and Baron. I think of these BOR possibly has the biggest upside from current prices but wonder what others think?
Don’t know what the potential at ZPHR is so may be worth a look?!