Member Info for Titania

OK write to the MP asking him/her to then forward to Therese Coffey. As you say she is new and wants to make her mark on things.

The most important thing is that we all write something to our MP this week urging at the end of the letter that they forward the letter to the relevant medical committee. It's a numbers game and a large pile of letters about the same thing can rarely be ignored!

I was thinking a more general letter saying the possibilities of SNG001 need to be explored again given the current rise in hospitalisations.

Synchronised writing to all our respective MP's can be effective? What do others think about that?

If a Government/health agency desperately wants a drug with a 93% probability of reducing progression to severe disease by 80% then they can authorise an appropriate Meta Analysis for SNG001 and if satisfactory results are obtained give it an approval. If hospitalisations continue to rise at the current rate and hospitals start to struggle this sort of decision needs to be balanced with mandatory masking or shutting parts of the economy and the huge costs that entails. I just hope that the UK government has all the required information to make these sorts of important decisions!

"It aims to help create a database of people who consent to be contacted by the NHS to take part in clinical studies, to help speed up the development of a safe and effective vaccine."

It almost sounds as if we haven't already got a safe and effective vaccine!

As interferon beta 1a is naturally occurring could he get a simplified approval in Switzerland?

https://www.swissmedic.ch/swissmedic/en/home/kpa.html

Probably not connected to Synairgen holding but posting for interest. Also down 90% this year!

"ZUR ROSE has a new significant shareholder: Reade Griffith has acquired a 3.2 percent stake in the mail-order pharmacy. He holds 2 percent of the votes in the form of shares, a large part of the difference in convertible bonds. Both emerge from a disclosure report to the Swiss stock exchange SIX."

"Griffith is not just anyone. The former European head of Citadel is considered a feared hedge fund manager. The American investor magazine Forbes once even described him as the "bad boy" of the hedge fund industry. Since leaving his previous employer, he has been running the two funds Polygon and Tetragon. Griffith holds the Zur Rose package through a sub-fund of Tetragon."

https://www.cash.ch/news/top-news/bad-boy-unter-den-hedgefonds-managern-nistet-sich-bei-zur-rose-ein-533951

TFG added 2 million shares and we are still down over the last month by 15%!
Weak sellers, clever trading or both!

Sorry for ranting on but it was a disappointment to me to read SNG001 classed as not available in the US rather than not approved in the US!

It would be nice to know that someone had discussed the possibility of a Meta Analysis with the FDA. No RNS on that so no dialogue with FDA presumably. After reading the covid guidelines I'm worried Synairgen is not pushing as hard as it could to potentially move to commercialisation. If the FDA say no then so be it but if you don't ask the question you definitely will not get.

Is that Phillip Monks judgement or FDA advice?

Shareholders ought to know if there is any sort of dialogue with the FDA or not?

"FDA officials participate in thousands of such meetings every year, dramatically increasing the predictability and efficiency of drug development.

Industry still complains that FDA moves the goalposts, but the situation is dramatically different from the time when the agency felt no obligation to provide insights into its requirements.

Academic critics have suggested that user fees and frequent communications with industry have led FDA to become captive to the industry it regulates to the detriment of patients.

Wood**** dismisses these arguments, telling BioCentury that meetings with companies benefit patients by avoiding unnecessary trials. “If development programs go on without knowing what the FDA expects, you are wasting the lives of people who volunteer to be in trials.”

https://www.biocentury.com/article/640486/how-wood****-has-changed-fda

Has Synairgen ever submitted a pre-EUA meeting request to FDA. Any dialogue with the FDA is either not occurring or not reported upon?

*have to have

As another poster said a while ago on here "To be turned down for an EUA means that you actually have to applied for one in the first place."

"Other interferons, including systemic interferon alfa or lambda and inhaled interferons, have also been evaluated in patients with COVID-19; however, these interferons (with the exception of subcutaneous interferon alfa) are not available in the United States. The trials that have evaluated interferon alfa and interferon lambda have generally been small or moderate in size and have not been adequately powered to assess whether these agents provide a clinical benefit for patients with COVID-19"

By omission they don't seem to pass any judgement on SNG001. We fall into the category of not available in the US!

Yes interesting!

P176
"Antiviral Drugs That the Panel Recommends Against
• The Panel recommends against the use of the following drugs for the treatment of COVID-19, except in a clinical
trial:
• Interferons for nonhospitalized patients (AIIa)
• Interferon alfa or lambda for hospitalized patients (AIIa) • Ivermectin (AIIa)
• Nitazoxanide (BIIa)
• The Panel recommends against the use of the following drugs for the treatment of COVID-19:
• Chloroquine or hydroxychloroquine and/or azithromycin for hospitalized (AI) and nonhospitalized patients (AIIa) • Lopinavir/ritonavir and other HIV protease inhibitors for hospitalized (AI) and nonhospitalized patients (AIII)
• Systemic interferon beta for hospitalized patients (AI)"

https://files.covid19treatmentguidelines.nih.gov/guidelines/covid19treatmentguidelines.pdf

Apologies if already posted!