Member Info for SYN00GOLD

Just added a few more !

He who dares Rodney, he who dares :-)

This does not relate to a submission error. The RNS was clear in that part.

'MHRA has indicated that it seeks a review by the UK Good Laboratory Practice (GLP) Monitoring Authority, or further support, of the non-clinical data submitted as part of the application to approve the clinical study. Sareum and its advisors are seeking additional clarification from the MHRA and will provide an update on next steps for resubmission as soon as possible.'

It may refer to additional preclinical data needed (further support ??) or some concern with conclusions drawn in some of the studies, but everything at this stage is pure conjecture. There will without doubt be a significant delay, as these reviews will need planning and execution and then more assessment. It does not mean there is anything fundamentally wrong. Just review and consideration. I could speculate like everyone on here but it will only be known from the written response by the MHRA CTA reviewers (on receipt). i.e. correct initial dose range vs. results in in vivo and margins of risk/genotoxicity and types of AMES/MNT/Big Blue/Safety Pharmacology findings and P wave, T wave, QT, QRS intervals, etc etc etc. All conjecture till Sareum pass on information.

Many clinical stages to get through yet and hurdles to overcome. This CTA is JUST to commence 1st stage in Phase 1, then P2 and then P3. We are at least 4-5 years away at the very least from a commercial product.

Wishing all well and good health.

I'm more than confident this will be over £1 before XMas !!!

Just games currently, a couple of these this morning tells you all you need to know :

71.734 250000 O

I love a slow short squeeze :-)

Morning again Oliver

This could pop at any moment. Can you imagine a sudden RNS special from Matt thrown into the mix. Shorts will be burnt alive :-)

Good morning Mr Shah, no Times write up of the recent upturn in THG fortunes ????

Next stop is 85p, enjoy the resurrection, and could come quicker than most suspect !!!

No RNS is a PI55 poor show from BoD, but I actually truly believe they are out of their depth and don't know what the actual preclinical data concerns from CTA reviewers are !!!

Prepare for a bad day :-(

Rebster: it could be anything !!!

The MHRA GLP inspectors will visit the Test facilities which conducted the preclinical studies and review as per the directive request from MHRA CTA reviewers.
At the moment we do not know which preclinical studies they have a concern about if any/and/or what Additional preclinical data that might be needed to support the CTA.

GLP inspector’s are a branch of the MHRA .

The entire CTA application relates specifically to Preclinical GLP studies

AnnacottSteel - I will be surprised if 85p is not smashed by weekend :-)

My guess this morning for todays SP was 70p. Hope we are correct or close. I actually hope we are way off target and the SP is £1.70p, I can dream !!

That is not the case IMO Bladey :-)

This does not relate to a submission error. The RNS was clear in that part.

'MHRA has indicated that it seeks a review by the UK Good Laboratory Practice (GLP) Monitoring Authority, or further support, of the non-clinical data submitted as part of the application to approve the clinical study. Sareum and its advisors are seeking additional clarification from the MHRA and will provide an update on next steps for resubmission as soon as possible.'

It may refer to additional preclinical data needed (further support ??) or some concern with conclusions drawn in some of the studies, but everything at this stage is pure conjecture. There will without doubt be a significant delay, as these reviews will need planning and execution and then more assessment. It does not mean there is anything fundamentally wrong. Just review and consideration. I could speculate like everyone on here but it will only be known from the written response by the MHRA CTA reviewers (on receipt). i.e. correct initial dose range vs. results in in vivo and margins of risk/genotoxicity and types of AMES/MNT/Big Blue/Safety Pharmacology findings and P wave, T wave, QT, QRS intervals, etc etc etc. All conjecture till Sareum pass on information.

It is NOT anything related to the GMP substance made in anticipation of P1 trial.

Many clinical stages to get through yet and hurdles to overcome. This CTA is JUST to commence 1st stage in Phase 1, then P2 and then P3. We are at least 4-5 years away at the very least from a commercial product.

Wishing all well and good health.

The MHRA are the UK medicines regulatory agency. There are many branches, GMP, GCP, GDP, GLP. The latter being the 1st of the testing of new potential pharmaceuticals. GLP certificates are issued after routine inspection cycles, depending on the size of the testing company.
The preclinical programme consists of a myriad of in vitro and in vivo testing of test items for safety and efficacy. Every single Study has a study plan. Raw data and report, which is signed by the Study Director and Quality Assurance. Once some of the package has completed I.e. genotox, ADME, some in vivo toxicology studies, reproductive tox etc the CTA commences.

My guess is the CTA reviewers have requested that some of these studies are given a review versus the raw data, for compliance with GLP standards and drawn conclusions. This will take some time depending on what the reasons are (and number of specific studies requested).

The big question is what is the actual areas of concern that the RNS does not go into.

?

Spread tighter than a gnats chaff........................someone wnats your shares :-)

Moving nice and steady :-)

Fly me to the moon :-)

Agree Moni :-)

Day traders scrape the penny trades, I'm also looking for the longer term > £3

As they used to say on an old comedy show 'Going up' :-)

I don't know EXACTLY when but sometime soon the shorters are going to start back stabbing each other and the SP is going to start flying.

I'm going to enjoy the bloodbath :-)

1st stop = 75p