Member Info for JoeyDiamond

There you go chaps Polar have been selling and buying back shares increasing there average holding hence the price action :)

The original P2 trial design and endpoints are a bit different to the P3.
Examples - P3 Being done only on WHO ord scale 4 patients.

Richard mentioned from P2 data it was far more worthwhile in amending the endpoints in P3. So I think P2 pivotal arms and trial have indeed been' forgotten' about now we have the new P3 and FDA aligned endpoints.

Indeed Mr Big it does also fit in with timelines for Synairgen starting in Q4. What is also interesting is SG018 trial hasn't appeared on https://clinicaltrials.gov yet which is strange as we are on the EU site https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004743-83/GB. P2 SNG trials were displayed on both websites. Admin oversight or more to it?

Previous research here has had US based Drs mention SNG001 was on an activ trial. Interesting theory though :)

https://clinicaltrials.gov/ct2/show/NCT04492475
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 30, 2020
Adaptive COVID-19 Treatment Trial 3 (ACTT-3).

This trail is using Rebif drug via subcutaneous injection.

Recently end endpoints were changed to be similar to Synairgens P3 trial design. Notably primary end point.

Primary Outcome Measures : Time to recovery for patients with baseline ordinal score 4, 5, and 6
***

So what will happen if there is positive data here? Likely there would be an approval for Rebif then this paves the wave for a superior delivery method of IFN-B1a to go on this trial.

Next week we will hopefully see some data.

Blessed22 some of your comments are incorrect.
RM said home trial results likely before P3 trial results. Other news like P3 start date will come first.
RM has advised we will get an RNS confirming P3 trial start and likely RNS for first patient dosed.
FDA will likely approve Phizer today or tomorrow.

The trial design / NIHR approval / Ethics approval all done. There are only 2 reasons I can think of delaying P3 start -

a) Manufacturing / supply chain approvals still to come through.
b) Xmas period is upon us and with possible resourcing issues regulators have advised the trial can start after this holiday period. Would it be normal to be dosing people through xmas period?

I have now personally pencilled in 28/29th Dec as likely start date. Hope im wrong and its earlier.

From RNS

'7digital is gaining momentum in each of our three key areas. Our strategy of focusing on social, home fitness and artist monetisation demonstrates our ability to create value for new markets in a rapidly evolving music industry. As we ramp up activity in these markets and continue to support and improve services for current clients, we anticipate substantial growth in our business and revenues in 2021.'

Lets hope they can keep the momentum up.

Its nice to see we have something to talk about other than tiktok and triller :)

I still don't understand what a convertible promissory note has got to do with Synairgen? They have not informed investors by RNS they used this method of funding.

'A convertible promissory note is a form of debt that converts to equity when either a certain event has occurred or a certain date has passed. The conversion from debt to equity will depend on the agreement between the person or company that has issued the note and the investor.'

Even if Synairgen did not inform investors of a note, the fact there are 200 million shares would mean the conversion has already taken place.

You think convertible promissory notes were in use? The fact that the placing shares were admitted to the market must have meant the notes were converted into equity already?

The AZN trial is currently halted worldwide due to a serious adverse event they are investigating. India says no to EUA at this time, FDA and EMA also unlikely to give EUA from what we hear.

Certainly looks like AZN will need to run further trials on half/full dose and actually provide good data this time to get an EUA around the world.

I have just read that letter, hopefully the FDA addresses these points in the meeting tomorrow.

https://twitter.com/EricTopol/status/1336447633926176768
https://www.nytimes.com/2020/12/08/business/covid-vaccine-oxford-astrazeneca.html

On the afternoon of Sept. 8, AstraZeneca officials had a conference call with the Food and Drug Administration. The discussion covered important ground: What would AstraZeneca need to do to win the F.D.A.’s blessing for the coronavirus vaccine it was developing with the University of Oxford?

But the AstraZeneca representatives neglected to mention a crucial development: Two days earlier, the company had quietly halted trials of its vaccine around the world, including a late-stage study in the United States. It acted after a participant in Britain fell ill.

The F.D.A.’s commissioner, Dr. Stephen Hahn, was stunned by AstraZeneca’s failure to disclose the halt to regulators, one of the people said.

More issues with the AZN data, some commentry

https://twitter.com/nataliexdean/status/1336344736718786561

https://twitter.com/TheLancetInfDis/status/1336343619381280768

Was an interim peer review - not been approved yet but considering members of MHRA are AZN shareholders should follow in coming days/weeks.

My mum works for NHS and all her team have been given Innova tests to take home. Supply lasts until Feb and they test twice a week.

This isn't to do with the vaccine but the fact they are frontline workers on Covid wards where regular testing is required for obvious reasons.

Interesting Boris reaffirming that the virus is being spread by asymptomatic people.
Then Han**** admitting the vaccine may not stop spread.
If the vaccine reduces peoples symptoms and disease severerity they will become asymptomatic spreaders.

Herd immunity may not be possible and lockdowns are gooing to be here for a long time.

So rest of world may struggle to get a vaccine to give their at risk populations as USA will corner the market and require near 1 billion doses- hence Synairgen shares just shot up.

Moderna and Phizer may well have all their vaccines taken up by USA once approval comes.

Now we see why UK rushed through their approvals without doing full analysis. They wanted to secure some of the Phizer vax.

Synairgen back in demand maybe.

https://www.foxnews.com/politics/trump-executive-order-coronavirus-vaccine-america-first

President Trump is expected to sign an executive order Tuesday that will ensure ALL Americans have access to the coronavirus vaccine before the U.S. government begins aiding nations around the world, Fox News has learned.

https://www.msn.com/en-us/news/world/covid-19-outbreak-at-canadian-mink-farm-infects-eight-people/ar-BB1bHw6R?ocid=msedgntp