Member Info for Aether

I think this is a very pessimistic take.

If this was mediocre data, RM would not be attending. These are key players in the industry. You would want to make a good impression.

There must be some gems from the deep dive data.

If anyone takes the time to read the WH post, it is obvious that Synarigen is potentially eligible for funding.

Tornadotony

Did you check with Synairgen about Active-2 P2?

This is relevant to SNG.

Taken from the WH post:

Launching the first-ever National Research Action Plan on Long COVID: Today, President Biden issued a Presidential Memorandum directing the Secretary of Health and Human Services to coordinate a new effort across the federal government to develop and issue the first-ever interagency national research action plan on Long COVID. The effort will advance progress in prevention, diagnosis, treatment, and provision of services, supports, and interventions for individuals experiencing Long COVID. This effort, building on the landmark Researching COVID to Enhance Recovery (RECOVER) Initiative and other initiatives across the federal government, will advance our understanding of Long COVID, foster the development of new treatments and care models, and inform services, support, and interventions for individuals experiencing Long COVID.

Accelerating enrollment into the RECOVER Initiative: Last year, the NIH launched its $1.15 billion RECOVER Initiative to advance our understanding of and ability to predict, treat, and prevent Long COVID. To help catalyze progress, the Administration will accelerate the enrollment of approximately 40,000 individuals with and without Long COVID into RECOVER’s longitudinal observational arm—in addition to advancing RECOVER’s pathobiology studies, EHR studies, and clinical trials. Equity remains at the center of the Administration’s COVID-19 response efforts, and RECOVER will focus on enrolling individuals across all ages, races, ethnicities, and socioeconomic statuses—including pregnant people, individuals with disabilities, and those from the communities hardest hit by the pandemic. RECOVER will also continue to bolster its patient-centered approach, leveraging its National Community Engagement Group—comprised of patient representatives across its pathobiology task forces and executive, steering, and oversight committees—to enable patients to shape research design and execution, listen for community feedback, and learn from patients’ first-hand experience.

Making further investments to advance Long COVID research and surveillance: Building on the $50 million CDC has already invested, the President’s FY23 budget has requested $25 million to answer key questions on the characteristics, risk factors, underlying mechanisms, and health impacts of Long COVID—through clinician engagement, electronic health data analyses, and grant funding. This includes through the Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE) study by CDC, which will follow nearly 6,000 individuals nationwide for up to 18 months, and other dedicated research in Tribal and other hard-hit, high-risk communities.

It could be mental illness or a personality disorder. Just don't feed its insanity. Greenbox it.

Don't feed it.

Bin it.

If the deep dive data for Long Covid has some gems, this could be very very good for Synairgen.

Federal money will be in place for them.

TO do happen without an EUA if the data is good. I I quoted an example a few weeks ago.

"He hasn't seen the Activ2 data and they are still going through the P3 data, he is basically asking shareholders to take a gamble that the data will be worth holding on for or am I missing something here?"

He hasn't seen the Activ-2 P3 data but must be reasonably confident because they passed to P3.
He has seen some of the SPRINTER 3 data and this must have given him confidence.

Otherwise why turn up at a prestigous event in May with industry leaders?
You turn up to broadcast your potential to relevant people.

"We need a JV or TO urgently."

Yes.

I'm getting the impression that they will continue with the research and trials route ad nauseam.

The SPRINTER trial indicates the product needs a larger pharmaceutical company to get to market.

The importance of political clout shouldn't be underestimated either.

A lot of your posts now look very prescient.

All this seems very important to establish.

Does Synairgen have a bio bank?

If not, can one be created either from existing blood samples in storage or by tracing patients?

Tornadotony states he has received an email from Synairgen confirming that there is no bio bank.

AnthonyW states that blood samples were taken for both Activ-2 P2 and SPRINTER 3.

***************
@aether they took bloods at day 0 determine immunogenicity in SPRINTER (its right above device training for patients in their protocol) . They also took plasma and serum in Activ 2 (presumably to determine auto antibodies and interferon expression). This isn't their first rodeo. They know more than most the difference in expression in patients.
***************

A bio bank is very important.

According to Tornadotony:

The key Billy was that the company did not secure a frozen blood sample from 610 people and secured its arrival back to Synairgen. If they had done so the company could have identified a laboratory test that would indicate when the Synairgen drug could be prescribed and save lives. The company was based in a Biobank facility. I was devasted when I found they had not done this routinely as the protocol was based on best efforts

Thank you for taking the time to reply, AnthonyW.

Tornadotony stated on 18 March:

**************************
My question concerned whether enough blood specimens had been collected and retained as a Bio Bank source for biomarker analysis in patients for both placebo and synairgen treated patients in the Sprinter trial. As promised I copied my reply here.

Dear Anthony,

Thank you for your enquiry and for your patience as we have responded to queries.

We do not have samples with which to conduct such an analysis. We remain in the process of analysing the topline and full dataset from the SPRINTER Phase 3 study. The findings of this analysis will be submitted to a peer-review journal.

Best,

Brooke
**************************

So, it appears they didn't collect samples.

Anthonyw - See Tornadotony's response from Synairgen when he asked this question. Given the implications, why didn't they?

Also, is it possible to trace patients and take blood samples now?

Let's hope they take blood samples in the next clinical trial for the reasons Tornadotony outlined. Why didn't they?

It is becoming obvious that this product and interferons work but to bring it to market they need a larger and more experienced pharmaceutical company.

I suspect there is still hope IF the deep dive data is good.

However, if it is to be commercialised a larger pharmaceutical company will be in a better position than the current company to do so.

I'm holding for a TO.

It is outrageous that they did not take a blood sample.

Could they now trace the patients and obtain a sample from them?

Thank you for taking the time to reply. It is much appreciated.

Tornodotoy - Do you think it will be possible to salvage some of the investment? £1 to break even.

Also, what do you think went wrong with the trial?

Thank you.

Does anyone want Synairgen to run another trial?

Not many, I'd wager.

I hope Polygon will keep them on point.

You can spot the recycling of phrases from the different sock puppets.

Green bin it.

Don't feed it.

Done.