Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
I would love to attend and get answers on what the hell they are playing at and why the utter contempt towards share holders by keeping us in the dark, but I could not stomach asking pertinent questions to receive the standard wishy washy answer to every question, "we are unable to answer that at present as it's commercially sensitive information " "we are unable to provide an answer to that at this time as we are in discussions with specialists/partners/experts etc"
The boards credibility is at an all-time low and I'm starting to question what exactly are they doing here, as everything is delayed or encounters problems, what are they actually doing with our investment money, in thec 3 years I have been here I honestly could not tell you.
Morning Belhus, that is of course a possibility but there is no evidence to support that idea what so ever. The lead horse based on evidence has to be an acqusition of 737 by Astrazenaca. It would just make sense as sierra had indicated an interest in developing SRA737 as a potential combination therapy following its in-licensing of the BET inhibitor AZD5153 aka SRA515 from AstraZeneca. Sierra was in the process of finalising trial designs for the three possible studies assessing SRA737 as a combination treatment, before receiving the offer from GSK. This is where I expect it to go to.
Read the artical below I have posted and then read our latest RNS, the problem is purely procedural or extra information. Nothing has failed and there is no problem with 1801 itself.
On a side issue SOG has been constantly making this point to keep all here calm and to provide reassurance to which I thank him for
This has helped to alleviate my concerns. Please have a read it's puts our predicament into context.
The Medicines and Healthcare products Regulatory Agency (MHRA) receives more than 1000 clinical trial authorisation (CTA) applications for investigational medicinal products (IMPs) per year. The great majority (up to 95%) of these are approved; however, more than half of all applications require additional information to be submitted before they are considered approvable. Many of the requests for further information or ‘grounds for non-acceptance’ (GNA), are common and are avoidable if available guidance is followed or if a satisfactory justification for not following the applicable guidance is provided in the application.
The statutory timeframe for initial assessment of a CTA application is 30 days with an MHRA internal target of an average of 14 days for assessment of phase 1 applications.
Currently, MHRA conducts an initial assessment of phase 1 applications within approximately 12 days and within approximately 22 days for all other phases. When GNA points are raised it can add up to 21 days to the final approval time for a phase 1 application and 23 days for other phases, depending on the time taken for the applicant to submit their response and MHRA assessment of that response.
Whilst these timeframes remain competitive and are well within the statutory 60 day period for final determination of a CTA application for a clinical trial of a general medicinal product, reducing any avoidable delays to the authorisation of a clinical trial is of benefit to trial sponsors and, ultimately, patients.
This guidance aims to assist applicants in understanding the common reasons for MHRA requiring additional information and provides direction to where further information and guidance can be found.
While this guidance covers many of the common reasons for MHRA requiring additional information during validation and review of a CTA application, it should not be seen as a ‘tick-box’ guide.
Every trial will have its own peculiarities and each is assessed on a case by case basis, which may lead to questions needing to be asked on specific areas. By the same token, sponsors who do not comply with some of the issues raised in this guidance might not necessarily receive a GNA if they have provided an acceptable scientific (safety) justification for not complying with guidance.
If sareum can release a proper RNS with detail on what has happened and how they plan to rectify it, we can all breath a sigh of relief take it on the chin and hopefully have a positive mindset with positive expectations. Until then sareum are doing themselves no favours and will be perceived as amateurs playing at it
Lazarus my thoughts exactly. Who on earth thinks ill release an RNS with a very vague reason for the CTA rejection, logic says this will smash the share price to bits, and affect market confidence in the company's credentials. I can't work out if this deliberate or extremei ncompetentence. The only rns that should have been released is there is a delay for this exact reason and we plan to rectify it with the amendment in this said timescale. I'm actually very concerned that the company is in a dire mess and this can't go into clinic for the foreseeable. This is the only logical conclusion that can come from the information to hand. We all want to think this is an admin error me included, but seriously look at the way this has been handled something is massively wrong here
Is complete transparency from the Board, some proper explanations on what the hell is going on. Every AGM is a complete waste of time, its the same old one liners, commercial sensitivity is rolled out. Stop the nonsense and show your share holders some respect. Starting with what happened to 737, what happened today and what the hell are peel hunt here for rather than simply hanging on like a parasite. Consolidation was a complete waste of time, HNWIs have been messed around, and here we are with an absolute mess of a company with not a single answer to any of the above points. Heads need to roll tomorrow
Fax what are you going on about? CTA rejections are fairly common for numerous reasons. It's not to say that it's the end of the road, it means they have to be resubmitted which takes another few months to get accepted. However if this is the case an RNS has to released acknowledging the mistake and the further hold up. They still get paid.
I think they have f*ucked the CTA application up, something is a miss here, as for trials starting this side of Xmas, what are they on about, there is less than 7 weeks until Xmas. We all want to remain positive but this is not how a company on the verge off aledged greatness conducts business. At best we can hope for a CTA application approval but a delay to trials is almost a given now with us well into November now
You are right in the fact that something is definately amiss here. I have a niggling feeling that the CTA application was not completed to meet the requirements for an approval, although the remedy would just be to rectify, amend and resubmit the application, the markets would punish us severely especially just having 737 kick backed, instantly halving the share price which would be a PR disaster in the short term. However with the recent upbeat RNS stating trials should be starting soon, I suggest this argument is becoming less likely. I'd have expected an RNS confirming the admin vcluster which Gunner was alluding to. I was in this camp a few weeks ago, but with every passing week logically this is less likely, I'm gravitating towards your line of thinking that a partnership is being lined up. The big question is with who? Stroke of genius by one of the leading pharmas if this plays out. You would expect them to have first dabs on an onlicence for both 1801/1802 if its as successful as expected. If it proves to be a dud walk away with minimal losses, surely a no brainer for all parties?