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Doc, Remember the board can issue another 30 million shares to try and prevent that scenario playing out.

Surprise surprise.....

Too true NDN, just ask my wife :-)

In terms of data analysis 4 weeks should be ample time for what is being undertaken but there are many moving parts here as well that need to be lined up IMO. Anyone who saw the presentation of the P2 data to media will know that a fair bit of work went into preparing for that and this time there will be a much bigger audience than a few UK journo's. There is also the question of manufacturing and scale up. One of the first questions they will be asked is how much they can supply and when (assuming positive readout), then there is the matter of EUA application. I expect they will want to have as much of this in order as possible on results day.

Just on the analysis I looked back and there were 16 workings days between unblinding of the P2 data and readout. Guess what day it is today....... the 16th working day since the data was unblinded!

I would be very surprised if this slips into February but of course it is possible.

Brand, it was then trialled in outpatient setting and showed some efficacy apparently. As far as I am aware it isn’t used in hospital setting.

They took the gamble on the 6th December so there really is no correlation as to what it would mean about when results will come out.

even better news.....they have 900k to sell WF.

Been like that since early December.

Hi Doc,

I just looked at some P3 hospitalised that had completed this year. e.g's

Regen-Cov was deaths at 28 days were 21% placebo group
Colchicine (Recovery) deaths at 28 days were 20% in placebo
Remdesivir was 15% but that was 2020 early in the pandemic

There are also a few studies on hospitalised mortality rates and they also range in the 10-20% range.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7920817/

Matt, Alpha correctly pointed out this morning that hospital trials that have completed had mortalities of approximately 20% for the placebo group so it would be unusual for this trial to be any different, particularly because of the points you make, but also becuase the baseline for participating meant that patient was already on oxygen.

Synairgen have every right to see the dataset once it is unblinded and locked. Once the data is locked whether SNG see it or anyone else it makes zero difference. No changes can be made to it at that point.SNG put together the statistical analysis plan for the protocol and that is what will be applied to the dataset.

For reference from the Committee on Strategies for Responsible Sharing of Clinical Trial Data; Board on Health Sciences Policy; Institute of Medicine.

" After study completion, investigators and/or sponsors clean the data, derive additional variables, adjudicate endpoints, lock the data set to create the full analyzable data set, carry out prespecified and additional analyses using software programs (the analytic code), and prepare manuscripts for publication. Investigators also can use parts of the analyzable data set to prepare analyses for presentations, data exploration, and hypothesis generation. A biostatistics best practice is to freeze a copy of whatever data were used in an analysis so the results can be repeated later if necessary. It is also desirable to store the analytic code that generated the results (i.e., the computer program), especially for any derived data."

https://www.ncbi.nlm.nih.gov/books/NBK286004/

That is not true at all. . There are a number of different companies involved in the data collection and analysis (Parexel/Transcrip/data Magic) not just one CRO.

If you look at the P2 study you will find that Synairgen were involved in the statistical analysis.

"The funder of the study had a role in study design, data collection, data analysis, data interpretation, and writing of the report. The corresponding author and coauthors had full access to all the data in the study and had final responsibility for the decision to submit for publication."

The company can report the result once they are completely satisfied that the statistical analysis is complete and the report is signed off by the board.

Thanks Brysoa!

Elsol, there were a number of statistically significant events in the P2 data. It wasn’t the fact that you couldn’t see statistical significance in the results it was that SNG didn’t understand/calculate what the power of the study was for the sample size. So whilst there were stat significant results the power may have been 70 or 80% based on sample sizes.

Also with the z score from memory in the protocol the z-score result in the interim study would signify 80% or greater statistical significance for the study to pass futility.

So whilst both are very positive indicators the P3 still needs to hit its statistical significance levels at a highly powered sample set.

One other positive for our P2 data that many forget was that the treatment group had a much higher percentage of severe disease (receiving oxygen) at baseline (77%) vs placebo group which were at 58%. This bodes very well for P3 IMO.

Agree Kev, There have been plenty of studies looked at this and mortality rate for covid is in the range of 10-20% for those hospitalised.

Nellie,

I think all shareholders would be ****ed if they raised capital prior to readout. The time has passed for that to happen in my opinion. Results are too close. I also struggle to see how they could justify a fundraise to large investors without P3 data to support it.

So you are heavily invested but then you are worried about dilution upon successful P3. I really don't get that mindset at all. Your current investment will be heavily derisked upon successful P3. The price will be north of the current SP and your buy in price so any fundraise post successful P3 would be at a significantly higher price to that at which you bought in at so the dilution effects would be minimised.

Where dilution will hurt is if the P3 fails and the company has to raise at a massive discount to the price you bought in at. I hope for all of us that we don't have to worry about that scenario.

A fundraise will be dependent on many different outcomes upon successful P3. Funds will be needed to upscale production but there are various options for this which include:

- BARDA funding support
- Upfront payment from pre-orders.
- Debt funding
- Equity issue

The author seems to neglect these other options and also the fact that if the P3 is successful then any fundraise will be a positive for the company not a negative.

I don’t think so WF. The P3 readout is so pivotal to this company I think they need to give the market time to digest the information and so can’t see it being released during trading hours.

Yes Doc. This isn’t a rebalance as I thought initially. Taking a little profit or doing an acacia :-) ...... we will see.

Inclusive you say? It appears my filter box disagrees!