Member Info for Greenfish89

Must be people who just brought shares making there money. So I guess it could go back down to 35 till they sell all thoses. Depends how many keep buying, whether it reaches 35 p or not

topped up this would still bagg if it was copd alone imo

But not what people hope and they might have huge dilution before hand as well. Good luck all holders

Wish I'd never invested

Wasted*

Wish I'd not wanted an hour of my life going through those protocols now.

so basicly it needs an aurthorisation and a favourable ethical opinion to change a drug trial end date in the UK i've not found any guidance as to how they make this choice but it seems to be two commities not a black or white thing.

https://www.hra.nhs.uk/documents/1775/RES_Standard_Operating_Procedures_Version_7.4_June_2019_lHKuibH.pdf
about page 247

Amendments normally requiring both authorisation and a favourable ethical opinionrequiring both authorisation and a favourable ethical opinion
• Change of the main objective of the trial.
14 “Significant”, i.e. likely to affect to a significant degree the safety or physical or mental integrity of trial subjects or the scientific value of the trial, or otherwise significant.
247
• Change of primary or secondary endpoints likely to have a significant impact on the safety or scientific value of the trial.
• Use of a new measurement for the primary endpoint.
• New toxicological or pharmacological data or new interpretation of toxicological or pharmacological data which is likely to impact on the risk/benefit assessment.
• Addition of a trial arm or placebo group.
• Significant change of inclusion or exclusion criteria (e.g. age range) likely to have a significant impact on the safety or scientific value of the trial.
• Change of a diagnostic or medical monitoring procedure likely to have a significant impact on the safety or scientific value of the trial.
• Withdrawal of an independent data monitoring committee.
• Change of IMPs.
• Change of dosing of IMPs.
• Change of mode of administration of IMPs.
• Any other change of study design likely to have a significant impact on primary or major secondary statistical analysis or on the risk/benefit assessment.
• Change of the sponsor or sponsor’s legal representative.
• Temporary halt of the trial or temporary halt at a trial site, and re-start of the trial following a temporary halt.
• Change of the definition of the end of the trial.
Amendments
so basicly it need an aurthorisation and a favourable ethical opinion to change a drug trial end date in the UK i've not found any guidance as to how they make this choice but it seem to be two commities not a black or white thing.

https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/research-ethics-committee-standard-operating-procedures/

https://www.hra.nhs.uk/about-us/news-updates/research-public-health-emergency/

https://www.gov.uk/guidance/managing-clinical-trials-during-coronavirus-covid-19 there is this page i'll keep looking

although DMC is the american one not sure about same clause in uk? anyone know where to look?

DAPA-CKD

DAPA-CKD is an international, multi-centre, randomised, double-blinded trial in 4,245 patients designed to evaluate the efficacy of Farxiga 10mg, compared with placebo, in patients with CKD stages 2-4 and elevated urinary albumin excretion, with and without T2D. Farxiga is given once daily in addition to standard of care. The primary composite endpoint is worsening of renal function (defined as a composite of an eGFR decline =50%, onset of ESKD and death from CV or renal cause). The trial is being conducted in 21 countries. The efficacy-stopping guideline in the trial protocol and DMC Charter state that after evaluating the totality of the available efficacy and safety data, the DMC may consider recommending that the study be stopped for overwhelming efficacy.

uk nhs page
https://www.nhs.uk/conditions/Clinical-trials/
they said 8 weeks, hopefully this will cut down lock down time.

https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html
I know this is cancer drugs but hope this helps

8 weeks from Monday just gone he said in interview so give it ten weeks as no one seems to have taken Scotties lesson to heart.

Anything over 900 ok for me

Have you even looked at the rns's. they have finance admitted ly if we don't rise a lot when ukog announce there results then we are for a huge amount of dilution. maybe we will get another resource estimate.

Musk is doing what!
on Quoth the Raven
He is making his workers work in close proximity in the Tesla factory even though the area is meant to be in shut down.
I hope they all take every penny off him.