Member Info for Silverfoil13

I guess that the CTN will be the next bit of news and as Australia is asleep between 7am and 4.30pm U.K. time then it is most unlikely we’ll hear anything during U.K. working hours. It will be a 7am RNS or nothing so nothing really to watch for during the day sadly!

Hi Falkirk
We have just had 16 glorious days in Lanzarote Playa Blanca .. great place and weather has been terrific every day! Never realised how nice it was and dining out is amazing!! Sadly home tomorrow but would recommend Playa Blanca to anyone for Spring or Autumn sunshine! Sure you are having a great time too!!!!

You’ve nailed it Potnak .. purpose of life! One of my sons said to me aged 7 .. Dad, you come from nothing is that right? Yes that’s right Ed! And when you die you go back to nothing is that right Dad? Yes that’s right Ed! Well what’s the point Dad? Potnak has now articulated the point of life .. try and enjoy every minute you can!! ps my kids are fortunately enjoying good lives and happily all earn more than us now so we can close down bank of Mum and Dad for a while pending our eventual departure!!

Thanks for that detail Sadoldgit .. always enjoy your posts .. incredibly informative

On a quiet ish day any thoughts on how CTN approval and a 737 licence deal might affect the price? If both happen I would hope to see a return to £3 to £3.50 (old 6p to 7p); I think if we got to those prices again I would be tempted to sell 25% of my current holding (after selling 33.33% in mid 2021); that would still leave me with 50% of my original holding for the next stage up

So sorry to hear that Salfordred. I’m sure the last 3 years were incredibly precious.

Interestingly the RNS relating to the the MHRA delay was issued after hours! So I guess if news drops in Australia before U.K. market opens they could issue the news immediately or at the usual 7am before U.K. markets open.

As we used to say on the way to the seaside .. are we nearly there yet?!!

Sounds like a lovely man; sorry to you and your family for your loss.

Nice one Speedy .. I would guess you are probably at least 40 years younger than me! I recall having a similarly balanced portfolio during the dot com boom but in technology stuff! Glencore, BR World Mining and Shell have been good stabilisers for me the last couple of years!

Trippytaka .. long time since I’ve been called an idiot .. pot kettle and black could spring to mind! I have a very structured investment portfolio split approximately 15 to 20% cash, 70% in safe stuff high yielding shares and investment trusts and 10 to 15% in high risk fun money! I have around 10 shares in the latter category .. some have been absolutely brilliant for me GFM, SAR, DANA, XAAR, Gamesworkshop and Telecom Plus where I have got the timing right .. some like GGP, BOIL and RKH have been terrible. RKH will come good, BOIL probably will too and hopefully eventually I’ll make something out of GGP but you can’t win them all!

Appreciate your comments Unimaginative .. I’m about £5,000 out of pocket but hopefully not all is lost!!

Glad this old dog has woken up! Got sucked in to it too late at just under 30p when it seemed like a no brainer .. and it seems like the only no brainer was me!!

A staged bail out is what I have always planned for SAR having failed to do this with other AIM shares and lost out through hanging on for too long. I sold a third of my holding at around 3.50 (old 7p) in 2021 and very happy with that. Will sell in tranches between £3 and £10 and probably keep around 5,000 shares beyond that for the long haul.

Interesting projections OIL
Back to £5 by 2030 Christ that was a long wait!
I’d like to see 50p by 2026 as first oil approaches. That will get me back above water for the first time in many years and I should still be alive then to enjoy that milestone!

I wonder if Navitas might pencil in first oil in 2026 in their report today .. I know someone who would be pleased!!

Duh .. so sorry MHRA (not MRSA) .. what a twot .. on holiday so not concentrating properly!! Good day though!

I guess in the near future there is no point wasting any more effort on writing to politicians or to MRSA. Until MRSA sort their act out can’t see anything to be gained through this activity any more. Just hope the Chancellors intention to fast track products in U.K. which have been approved abroad is followed through although frankly I don’t trust the current bunch of politicians to do anything they say!

To MHRA
Dear Leonard

Many thanks for your reply to my query about ongoing, serious and unacceptable delays in CTN and CTA applications at MHRA which are forcing U.K. companies like Sareum to go abroad to seek approvals for their potentially life enhancing and life saving drugs.

I appreciate the response but find the whole situation totally unacceptable and an embarrassment to the MHRA.

Sareum made its CTA application for its 1801 product to MHRA on 28 July in the expectation of a timely response so they could commence trials in Q4 2022. Could you confirm what is the normal time frame for a CTA application to be approved; I understood it was 30 days.

Sareum were advised by MHRA on 8 November (so over 100 days) that they were seeking a review and further support re non clinical data. No detail was attached to this delay and although Sareum have sought further clarification of what is needed sadly MHRA have not provided this.

They still have received no further update from MHRA so have been forced to set up a CTN in Australia. It is a farce that a U.K. company has been forced to do this.

Can you confirm how long it should take MHRA to respond to an application for a CTA; how long approvals should take; are there problems and delays generally at MHRA at the moment; how many applications have been made to MHRA for CTA approvals since 28 July; how many have been accepted, how many have been rejected and how many are in limbo as with Sareum.

If you cannot provide this information I will make a FOI request for the information.

I look forward to hearing from you.

Kind regards

On 22 Mar 2023, at 09:04, MHRA wrote

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Dear Clive

Thank you for your email dated 15 March 2023 re IMPORTANT: Sareum 1801 Clinical Trial Application

Thank you for contacting the MHRA. Due to confidentiality reasons we are unable to provide comment on specific clinical trial authorisation applications to anyone other than the applicant or someone authorised by the applicant to receive such information. However, we can reassure you that your concerns have been noted and will be used to identify any improvements that are needed to our processes.

We trust that this resolves your request.

Our opening hours are Mon – Fri 08:30am to 4:30pm (excluding UK Public Holidays)

With kind regards

Have received a response from our MP also from MHRA.
Response to and from MP follows and will update re MHRA later today

Dear Andrew

Many thanks for your reply which is greatly appreciated.

It is a source of major concern that Sareum and clearly other companies in the bio pharma industry are experiencing similar difficulties with MHRA firstly because their research has potentially life enhancing and life saving benefits but also because companies are beginning to look outside the U.K. for testing and approval which is the opposite of the governments stated objectives.
Clearly something is amiss at MHRA if such long delays are being experienced and hopefully Will Quince can throw some light on this.
With thanks again
Best regards
Clive

Sent from my iPhone

On 22 Mar 2023, at 10:08, Andrew Griffith MP wrote:

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Dear Clive,

Thank you for contacting me about the treatment approval process in the UK.

The drug approval process in the UK is extremely rigorous, in order to ensure that treatments provided to patients are safe, as well as being effective. All treatments are required to undergo stringent clinical trials, licensing, and appraisal by the National Institute for Health and Care Excellence (NICE) before being made available on the NHS.

NICE processes have been designed to offer the best possible treatments for the best possible prices, protecting patients and taxpayers over pharmaceutical companies. I fully support NICE, who do a very good job in difficult circumstances, and believe that an independent assessor is vital in ensuring only the best and safest treatments reach patients.

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.

I welcome the decision by NICE to reform 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 streamlining the process for Highly Specialised Technologies.

Additionally there was recently an announcement of a change to the UK’s drug approval process, whereby a reciprocity system will be introduced, first with the EU and with the aim of expanding to other recognised countries, allowing drugs approved in those nations to receive approval for UK markets within 67 days.

Whilst I am confident that in most cases our treatment approval process is effective, I was concerned to hear of the matter you have raised. I will ensure to raise this issue with Minister Will Quince and I will share any response I receive with you.

Thank you again for taking the time to con