Member Info for ChrisToffer

Its normally a certain amount of shares dependent on how many you hold. Not in the RNS so must yet to be decided by the brokers.

They must be confident of raising £87 million quickly with such a small discount!

Interactions with the European Medicines Agency ("EMA") are ongoing.

Following a positive pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) regarding the design of a Phase III randomised placebo-controlled trial of SNG001 in hospitalised COVID-19 patients, and with manufacturing scale-up activity underway, the Company is pleased to announce the proposed Fundraising of up to £87.0 million to support the Phase III clinical development and supply chain scale-up of SNG001 for COVID-19 patients.

He's a Cabbage! I wish he'd leave the board and lettuce all live in peace.

Thanks Hodgson, that looks like the improvement in testing that was referenced in one of the first trial amendments.

Completely agree WedMe - the idea that a host of other therapeutics in development are catching up or pulling ahead is preposterous. The approval process (with the exception of some variance) is the same for everyone. SNG001 had a huge head start on most. There may be 1 or 2 that get accelerated off the back of political pressure (e.g coavalescent plasma/regeneron) but the idea that approval protocol and the agencies who enforce it will buckle and bend to disadvantage SNG is utter nonsense as it would completely undermine the authority's position on such matters.

This document that was shared the other week is dated for April - an absolute age ago in the context of drug development for the pandemic. There wasn't enough inhaled interferon available because SNG made the decision to run their own trial because it was the fastest way to establish the trial and complete recruitment whilst maintaining quality control.

That decision has led to them producing a high quality hospital dataset. It may also be why the government have since been shy with their support.

This biggest issue for me, as pointed out in the interims, is the governments lack of support in promoting the at-home trial.

Thanks Grizzler! Shame that it seems they didn't promote the at-home trial.

"Yes. Synairgen sng001 is inhaled Interferon 1beta. It's a lifesaving biological drug that few of us will have access to should we contract COVID-19"

Only one way to fix that, it'll be 4 billion mate.

Hi Skeletor, my understanding is that the deal with clinigen will not fill the 100k a month. It only allow sales to those who really need it straight away so those numbers would be unrealistic. However it will smooth the transition to mass supply in the event that EMA is granted. Each EU country will have its own degree of red tape even after an EMA.

The US and FDA seem to be an entirely different matter as the Clinigen agreement, even though they have US presence, is for the EU only.

Miggy, I think Eleanor Fish was on a lot of those early Cuban/ Chinese studies? There was an article shared this morning where she was suggesting the use of Interferon Beta specifically (as opposed to alpha).

Hewhodares, yea thats right! It was a lot of those early reports that encouraged me to invest so heavily. What we've seen over the last several weeks is the scientific validation of them.

And still no argument against it.

There was a non-peer reviewed study released several months ago about a hospital in China giving their front line staff inhaled interferon (might have been alpha). None of them caught the virus.

This would obviously all have to be validated in clinical trials but the potential for SNG001 as a prophylactic is there.

Bought at 139, sure ya did!

The demand for treatments in the face of rising european numbers mean we're almost certainly going to have a ground breaking RNS before Jan.

Trade this share at your peril! It would take a long time trading this share to achieve the same sort of gains that were had from just buying and holding over the last few months!

I've just been reading the development of Azedra which had a MAP (for outside the US) agreement between Clinigen and Progenics announced in October 2019. Bare in mind this is a cancer treatment that comes with huge side effects;

04 June 2018: Pivotal Phase 2 trial data on 68 patients announced with positive results
30 July 2018: FDA approval granted
9 Oct 2018: Results published in Journal Of Nuclear Medicine
10 Oct 2019 (a year later): MAP agreement announce with Clinigen

I will be astonished if we don't see FDA approval this side of Christmas.

Did someone mention a LEEK?

To sell 100k treatments a month through the MAP avenue alone would be unrealistic which is obviously why they are still talking to the agencies on approval.

1 in 20 people suffer from long covid and the active EU cases at the minute are over 2 million. 2 million X 0.05(1/20) = 100,000.

That's just for the UK/EU.

Parsley you're only moaning cause the current SP movements don't suit your short term trading strategy. The fundamentals haven't changed and the potential for huge gains are here for those willing to trust their own research.