Member Info for Matml74

Tommy, OSCI level 3 is considered mild disease hospitalised but no oxygen therapy and OSCI level 2 is Ambulatory with limitation of activities so I expect anyone discharged would be considered level 2. They would continue taking treatment for the full 14 day period whether they were in hospital or not as that is the dosage regime.

Tommy, Time to recovery to OCSI 1 is also a primary endpoint hence the need for these questions to follow the patient through to day 28. Its plausible patients are discharged before they get back to level 1 on OSCI scale.

WF, The trial was started prior to any vision of the data by SNG or regulators so more of a quality assurance measure than any read of the data IMO.

From SNG website......

" This is a pilot trial requested by regulators to validate the additional questions that are included in SG018 which determine the OSCI score when patients have been discharged from hospital. The study is proceeding on time and as it is an independent study, will not delay the SPRINTER study (SG018)."

Great post. We are watching the transition from a clinical research company to commercial pharma co in a very short space of time. Very exciting.

....... plus two directors of CMC added in the past few months

I'm sure nothing will get past you gggg!

The new manufacturing roles tell the story. Positive data and launch coming soon.

"But with trial end date as 31 Jan, we won’t hear for another possible few weeks while that’s analysed and added into press release etc?"

Waite, Its a 25 person QA study. It won't be part of the P3 results data release. It will be part of the data package provided to regulators for any EUA application. It certainly won't be holding back release of P3 data and it is very unlikely that we will ever see any of this data anywhere.

It is part of the QA/QC. It’s likely in the SAP and was always going to happen.

The questions aren’t asking for new data it is check that the questions asked through the trial to assess patients OSCI once they were discharged from hospital were easy to understand.

What this small study (25 people) is doing is asking the patients about “ their relevance, ease of understanding and clarity needs to be shown, which is why this interview study is being conducted.

Basically finding out if patients found the questions easy to understand and their relavence to symptoms.

This is just tidying up clinical trial database prior to readout.

I don’t see how this relates to long covid at all. Its just an assessments of then methodology used in the trial for both primary and secondary endpoints.

Doc, it is a quality control check of the OSCI methodology used in the trial is easy to understand for patients. Nothing iffy about it at all.

Also the end dates on these registers are arbitrary and movable as we have seen with SG018.

Not according to Nov 11th rns.

"Once the final patients have completed the initial 35-day trial period, quality assurance and statistical analysis will be completed. Accordingly, as communicated previously, top line data from the trial is expected in early 2022"

If they were waiting for 90 days they would have said.

3 years refrigeration
5 years freezer

Think it was reported in results September 21 rns.

Matterhorn,

Micronisation is an important part of getting INF B to the required particle size for effective nebulisation of drug deep into the lungs. It may be part of the fill/finish procedure for SNG, but you are right none of us know the full manufacturing process. I think Akron produce the drug and then the Catalent get the drug into solution at the required particle size.

Have a read of the below and will outline how this may relate to SNG001. Whilst the document is not SNG related it describes how it is important to get particle sizes to effective aerosol deployment via a nebuliser and is based around INF B.

https://patentimages.storage.googleapis.com/1f/d8/ff/ed2ec4e813c086/EP0477386B1.pdf

Micronization is a cruicial step in getting INF B to the required particle size (5 micron or less) for efficient deposition in the pulmonary region. Larger particles get deposited in upper respiratory tract.

A high proportion of those hospitalised in the US are overweight or obese. One study put the figure at 78%.

Further recommendation of SNG approach to treatment.

"Additionally, the study also demonstrated that tissue immune cells in the respiratory tract of Ob SARS CoV-2 patients had a markedly lower response to type I IFN and IFN-? and their transcripts. Hence, the findings support the therapeutic strategies with locally delivered inhaled recombinant type I IFNs to respiratory tract tissues in this patient group."

https://www.news-medical.net/news/20220124/Attenuated-tissue-immune-responses-against-SARS-CoV-2-in-obese-and-non-obese-patients.aspx

Both filtered Doc so they can roll all they like ;-)

'My guess' is that Polygon dumped some shares to drop the price, scared a few more PI's into handing over their shares...... again...... and have filled up their vault of SNG shares further buy buying from low 170 back to 180. Rinse repeat over and over again...... and people still fall for this every time.

Great work WF. Unsurprising really.

Thinshins, SNG001 is an immunomodulator. It does not act directly but against the virus likes MAB’s or the pills. The documents I have read by the fda have only requested in vitro work for those drugs that act directly against the virus. The genomic changes between this variant and the previous ones are very small, although they have big effects on effectiveness of vaccines and drugs that target specific parts of the virus. SNG001 will be unaffected by these changes due to its mode of action.

However I expect SNG will do the in vitro work as they will leave no stone unturned. Data is king as RM would say.