The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
While we wait with bated breath the 10 days have come with no word from the lab, no news is very good news in this case. From 4th sept RNS ............. "Dosing has started at a specialist clinical unit in Melbourne, Australia, and subjects will receive SDC-1801 orally once daily for 10 days"
Been sitting on the edge of the chat lately Watching the doom mongers come and go, the news from Sareum has always been positive despite the de rampers and MRAH disruption that we now know was down to their own incompetence. Sill a chance to buy at less than 2p old money seems like a bargain imo. All LTHs will know when she blows she blows high and mighty. Sit back and enjoy the ride to the AGM. We will need some loaded questions to try and prise the board into giving something away.
GLALTH
Has anyone looked at similar trial for a smigging of comparison ie the BMS trial @ https://classic.clinicaltrials.gov/ct2/show/NCT03611751
Bit above my paywall but I’d hope some of our resi boffins would be able to study and come up with some interesting viewpoints.
GLA
It’s No one on heres fault on the response delay from the email complaints some of us thought was appropriate to send to our MPs. Imo it’s good to share so we know how the SAR board have been treated by the bodies involved with any application.
Those of us who used the template or wrote separately when asked by a poster on this BB, should be welcome to post any response if they so wish. After all it’s information and that what we are all here for, good, bad or indifferent.
Num4 this is what I sent, it was a template posed by someone on here at the end of March.
Dear Grant
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.
Yours sincerely
For anyone interested yawning
hope you’re well – thanks very much indeed for taking the time to contact Grant, I’m responding on his behalf. I’d first just like to extend my sincerest apologies for such a delay in getting back to you – this is down to an administrative error in transferring your enquiry over to our caseworking system and assigning it to the correct inbox.
Grant’s really grateful to you for getting in touch about the delays being experienced in the UK’s drug approvals process. To ensure treatments provided to patients are safe and effective, it’s an extremely rigorous one – and each new drug or treatment has to of course go through the steps you’ve mentioned that Sareum feel are currently easier to go through in Australia. The appraisal from the National Institute for Health and Care Excellence (NICE) and its other processes have been designed to offer the best possible treatments for the best possible prices, protecting patients and taxpayers over pharmaceutical companies – Grant fully supports their work, and it’s his view that an independent assessor is vital in ensuring only the best and safest treatments reach patients.
As I’m sure you know, in the UK treatments are approved on an evidence-based approach, rather than an anecdotal approach. Clinical trials must be ethically robust and impartially observed, in order to ensure that the results of the trial are independently verifiable. This is crucial to protect patient safety. Without rigorous clinical trials, medication cannot, and should not, be licensed or distributed. But, perhaps most importantly and relevant to your concerns, NICE has committed to reforming its decision-making process to give patients earlier access to innovative treatments. These changes will place greater emphasis on health and medical benefits, improve how real-world evidence is used and streamline the process for Highly Specialised Technologies. It goes without saying that Grant absolutely welcomes this decision.
I do hope all of this is ok, and my apologies once again for such a delay in getting back to you. As always, if there are ever any other issues you’d like to discuss, please don't hesitate to get in touch.
Kind regards,
Joe Smith
Parliamentary Assistant | Office of The Rt Hon Grant Shapps MP
Apologies if this is a repost
Sra 737 is among the active runners
https://www.globenewswire.com/en/news-release/2023/05/10/2665893/0/en/Checkpoint-Inhibitors-Clinical-Trial-Pipeline-Appears-Robust-with-180-Key-Pharma-Players-Actively-Working-in-the-Space-Estimates-DelveInsight.html
Gutted to have this sad news confirmed, my sincere condolences to all Andy’s friends and family, please excuse the inquisitive questions as T2 would have told you if he were here, there a cynical lot on here.
I can’t see what anyone could gain from posting this sad news. I hope we as fellow shareholders can mark his passing with a fitting tribute, Whatever the family chooses. Take care of your wonderful family and if his daughters are anything like Andy I’m sure they will flourish. Give them a hug and kiss from me.
XXXX
Don’t think the Guardian has a pay wall
Link below
https://www.theguardian.com/business/2023/may/13/plunge-in-clinical-drug-trials-makes-britain-an-urgent-case-for-treatment