Member Info for dafad

Have a look at all the other co's who have recieved fda fast track-just look at their share price graphs

nairgen plc

18 December 2020

Press release

Synairgen plc

('Synairgen' or the 'Company')

COVID-19 Clinical Programme Update

- SNG001 given Fast Track designation and IND cleared by the US FDA
- Phase III trial design adapted which will expedite results
- Phase III trial to commence dosing in UK imminently
Southampton, UK - 18 December 2020: Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, today announces updates to the Company's Phase III trial design evaluating SNG001 as a treatment for patients with COVID-19 and positive progress on the regulatory path.

Update to Phase III trial (SG018) protocol in COVID-19 patients

Following discussions with the regulatory agencies, the trial has been amended as follows:

-- Removal of the lower dose arm, thereby reducing the number of patients required to complete the placebo-controlled trial from 900 patients to 610 patients

-- Addition of a second primary endpoint. The primary endpoints are now 'time to hospital discharge' and 'time to recovery'. The primary assessment of efficacy will be supported by the key secondary endpoint of 'progression to severe disease or death' and other secondary endpoints. Both primary endpoints have at least 90% power to detect a statistically significant effect of SNG001 compared to placebo

-- Addition of assessments for Long COVID-19 symptoms on day 60 and day 90
Initiation of the first SG018 sites has commenced in the UK, with dosing expected to commence imminently. The SG018 trial was deemed an Urgent Public Health study and recognised as a National Priority by the National Institute for Health Research (NIHR) in October 2020.

Investigational New Drug clearance and Expedited Regulatory Pathway granted from the FDA

Synairgen's Investigational New Drug (IND) application to the FDA to evaluate SNG001 as a treatment for patients with COVID-19, has been cleared, enabling Synairgen to initiate its SG018 trial in the US. Furthermore, the FDA has awarded SNG001 Fast Track status, enhancing the ability of Synairgen to interact with the FDA and shortening review timelines.

Update on the SG016 home trial in COVID-19 patients

This trial targets patients with a positive SARS-CoV-2 test result who are aged over 65 and those over the age of 50 with 'high risk' medical conditions. It is a trial designed to make it easy and safe for trial participants and researchers to conduct the research; all supplies for the trial are delivered directly to the patient's door by courier, and all trial visits and assessments are conducted virtually by video call. After a slow start in the summer, recruitment and dosing are now progressing well with a noticeable increase in the last two months. Those interested in participating in the trial can visit www.covidtrialathome.com .

Richard Marsden, CEO of Synairgen, said: "With this adaptation we should be able to reduce the time taken to complete th

https://mobile.twitter.com/INASEEMIN24/status/1338622834151739394/photo/1

https://twitter.com/EricTopol/status/1338560047450791939/photo/1

.

https://www.youtube.com/watch?v=WKdCOXxtNBA

Watch from 25min 11sec
The BUT at 29 min 17 sec is very iteresting and he is somewhat miffed atthe WHO panel

https://www.youtube.com/watch?v=2lA5_WxP5nQ

UK drugmaker AstraZeneca has agreed to buy US biotechnology group Alexion in a $39bn deal, marking the biggest deal struck by a pharmaceutical company since the start of the Covid-19 pandemic

RNS OUT

anofi SA said Friday that the Covid-19 vaccine program it is developing with British pharmaceutical giant GlaxoSmithKline PLC has experienced a delay.

The French pharmaceutical major said the program was to improve immune response in the elderly, but Phase 1-2 interim results showed insufficient immune response in that group.

Sanofi said the reason for the low immune response was probably an insufficient concentration of the antigen utilized, and that the two companies are planning a new study with an improved antigen formulation to start in February 2021.

The vaccine is now expected to become available in the fourth quarter of 2021, pending completion of the development plan.

DMEEE

RNS Number : 1253I

Empire Metals Limited

10 December 2020

To view the announcement with the illustrative images and diagrams please use the following link: http://www.rns-pdf.londonstockexchange.com/rns/1253I_1-2020-12-9.pdf

Empire Metals Limited / AIM: EEE / Sector: Natural Resources

10 December 2020

Empire Metals Limited ('Empire' or the 'Company')

Further Positive Drilling Results & Completion of 75% Acquisition of Eclipse Gold Project

Empire Metals Limited, the AIM-quoted resource exploration and development company, is pleased to announce an update relating to its Eclipse Gold Project, located 55km north-east of Kalgoorlie, Western Australia ('Eclipse' or the 'Project').

Overview

-- Initial work programme completed at Eclipse has increased confidence in the Project's potential to host a profitable small-scale high-grade open pit gold mine

-- Further significant assay results received to date include:
o ECRC20_022: 14m @ 3.78 g/t gold ('Au') from 22m, including 1m @ 21.4 g/t Au, and 1m @ 16.65 g/t Au - This hole includes three different clusters of quartz veining mainly associated with the higher grades, confirming there is more than one mineralised structure

o ECRC20_027: 8m @ 2.27 g/t Au from 32m including 3m @ 5.27 g/t Au

o ECRC20_032: 5m @ 6.50 g/t Au from 26m, including 3m @ 9.29 g/t Au

o ECRC20_017: 3m @ 3.18 g/t Au from 49m including 1m @ 6.49 g/t Au

o ECRC20_026: 1m @ 6.93 g/t Au at surface, and 1m @ 4.50 g/t Au from 10m

o ECRC20_021: 14 m @ 1.70 g/t Au from 9m depth including 1m @ 7.76 g/t Au at 9m and 4m @ 2.37 g/t Au from 19m

-- Additional work programme to commence before year end including infill and extension drilling at Eclipse to better define the near-surface potential resource and extensions at depth and along strike, in addition to target testing at Houdini and others defined from geochemistry

-- Completion of 75% acquisition of Eclipse through execution of option agreement following fund raising completed on 24 November 2020

Mike Struthers, CEO, said: "We are pleased to have now exercised our option to acquire a 75% interest in Eclipse which, coupled with the Company's recent placing, allows us to push ahead with developing the Project. These additional drill results in the uppermost 50m of Eclipse are very encouraging and add further to our confidence in the potential for a profitable small-scale and high-grade open pit operation. This is very attractive, but the fact that the Eclipse mineralisation is also open at depth is particularly interesting and will be a key element of further work as we continue to advance the Project.

"The Company is also expecting to receive a permit in the near term for drilling further to the north-west along the strike of Eclipse, in the vicinity of the other old workings of Jack's Dream and Steinhobel. These lie 200-300m north-west of the Eclipse shaft, on the same mineralised structure. Jack's Dream was worked in

Fish Supper Promised for tea

Let's hope for a lobster pot of gold fish

@40.5p

Only 14 trading days left

I wonder what will happen when the first reports of a bad reaction to the vaccination is reported.imho it is bound to happen

He asserts that interferon has its share of detractors who believe the drug “threatens to upend the pharmaceutical bottom line.”

https://www.kirkusreviews.com/book-reviews/joseph-cummins/case-for-interferon/

post no 27470

rRumour on a d v f n poster named Nobbygnome

Could we be a treatment for Flu as well as Covid in the future

https://khn.org/news/breakthrough-finding-reveals-why-certain-covid-patients-die/