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Thx for that gunto2020 - nothing much then.
I have no idea when Synairgen was added to this list, but I quite like us being part of this club. May it be a sign of good fortunes.
https://www.accessdata.fda.gov/scripts/SDA/sdDetailNavigation.cfm?sd=srolist&id=D61867CCC84402B7E0531498C30A6709&rownum=25
What are Significantly Regulated Organizations (SROs)?
HHS (Health & Human Services) Supplemental Standards of Ethical Conduct formally defines SRO as
- "an organization for which the sales of products regulated by the Food and Drug Administration (FDA) constitute ten percent or more of annual gross sales in the organization's previous fiscal year;
- where an organization does not have a record of sales of FDA-regulated products, it will be deemed to be significantly regulated if its operations are predominately in fields regulated by FDA, or
- if its research, development, or other business activities are reasonably expected to result in the development of products that are regulated by FDA."
Who are restricted from holding financial interest in SROs?
FDA employees as well as their spouse and minor children are prohibited from holding financial interests, like stock, in certain businesses regulated by FDA.
https://www.fda.gov/about-fda/ethics/prohibited-financial-interests-fda-employees
lol - no one is going to apply for these roles if they're based in Uk, Irkutsk, Russia. Some serious fat finger there!
But, agree it was super fast. I guess they liked what they saw and closed it.
# of applications per role.
Head of Market Access EU - 11
Head of Medical Affairs EU - 5
Head of Commercial Operations EU - 22
Doc83 - not necessarily. It's a bit like the principal of diminishing returns. Good candidates will apply as soon as a role becomes available.
No it does not mean the roles have been filled. It just means they do not accept any new applications. Next steps will be to shortlist the candidates before starting the interview process.
Data is unblinded (and remains unblinded) immediately following completion of the day 35 visit of the last recruited patient. Note data is unblinded for the sponsor.
It's speculated that top line results are not to be released prior to completion of the day 90 visit of the last recruited patient to prevent the introduction of a new bias.
It will be a while before results are reported for all the primary and secondary endpoints. Peer review will take place only once the company has analysed all of the data themselves and made it available for such a review. It will not be on 01 Mar 2022.
Just to add. I suspect this is the original peer review publish date when the original trial recruitment end date was Jun 2021. So just ignore it. The individual responsible for updating the protocols aren’t great at it - makes many mistakes.
Doc83 - top line data is always published long before a peer review.
01 Mar 2022 is the intention to publish in a peer reviewed journal. It does not refer to top line data.
Alkin - Brooke Clark is a PDMR (person discharging managerial responsibilities ), not her husband who is classified as a PCA (person closely associated). As far as I can see restrictions on dealing during closed periods are only applicable to PDMRs, but not PCAs.
The company has an obligation to report to the market any dealings by a PCA.
Correction - my comment related to the ‘Tic-Tac-Toe‘ thread.
There’s nothing to suggest this relates to Synairgen, so nothing to get excited about unless someone can say 100% Catalent will do production in the UK for Synairgen.
Another thing to consider is the possibility that Synairgen will shift over to BFS should the initial manufacturing tests be successful.
It’s highly likely they had a peek at interim data as you suggest Matml74. They must’ve had to enable planning & putting in place all the required structures.
The Delaware based US entity was incorporated on 26 Oct 2021. This could just be when preparations got off in all earnest.
Thank you ohdannyboy. Brilliant.
For the first time, with regards to SNG, I’m having an unadulterated grin :-)
623 was known back in December. Scroll down to just under halfway.
Fruits - I guess they continued to state 610 in their comms as that has always been the official target referred to from the outset and to not cause some confusion.
https://www.isrctn.com/ISRCTN85436698?q=ISRCTN85436698&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search
It seems like ACTIV-3 (hospitalised patients) has stopped early the trial of Pfizer’s intravenous paxlovid based on disappointing early data. That leaves the future of ACTIV-3 in doubt as all agents trialed failed.
That sure does leave SNG001 in a unique position.
https://www.fiercebiotech.com/biotech/pfizer-a-rare-covid-19-setback-dumps-paxlovid-s-intravenous-sibling-to-leave-activ-3-future
It may have been an old video, however an interesting comment was made by Dr Davey which I highlighted and had hoped could be discussed.
Ducati2 – thanks for the video. I’m particularly interested in the second part of Dr Davey’s comment on inhaled interferon. This is the first time I’m hearing an expert publicly referring to this.
Here’s what he said: ‘… and I think some of the immune modulators like inhaled interferon might hit both, be an antiviral and also change the inflammatory landscape.’
Quite a bit had been written about late stage interferon treatment potentially causing inflammation, but none (as far as I know) of the experts have ever mentioned anything about the regulatory role interferon beta might play with regard to inflammation. The lack of reference to this particular fact has ‘bothered’ me quite a bit for a while now, potentially even irked me.
I’m not a medical or scientist by profession so of course I might be missing something. It would be great if some of the erudite members of the board can opine as to what the possible reason(s) for this is. Maybe it’s something that is not well understood yet. I don’t know. If we look back at the phase II results some patients were at day 10 when treatment began which is quite late, yet they recovered without any issues. Bearing in mind it was a small trial so could’ve been ‘pure luck’.
A few quotes:
‘Data are now emerging that suggest that type I IFNs are also important mediators of anti-inflammatory responses. ‘
https://www.science.org/doi/10.1126/stke.4162007pe70
‘Interferon beta (IFN-ß) induces the phosphorylation of signal transducer and activator of transcription (STAT) proteins through the activation of its own receptor, modulating the secretion of cytokines and chemokines which regulate inflammation. However, the role of IFN-ß and STAT proteins in modulating the inflammatory response of CF remains unknown.’
https://www.frontiersin.org/articles/10.3389/fphar.2018.01368/full
The notion that Type I interferons (interferon-a and -ß) possess anti-inflammatory potential is supported by data from clinical application in multiple sclerosis, by studies on cultured immune-competent cells and by investigation of experimental diseases in whole animals. These observations deserve the attention of virologists for their potential role in the pathogenesis and clinical management of virus infections.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7114336/
Remember, Polygon is in the business to maximise profits, it’s a hedge fund, and by that they mean MAXIMISE. There is no halfway house. If they’re acting on behalf of someone else and sell to this party on the ‘cheap’ they would seriously damage their reputation and infuriate their investors as they would’ve failed to execute their fiduciary duty which could cost them current and/or new investors.
This is their strategy - copied from their website. ‘We believe we are in the business of maximizing investment returns, rather than building AUM.’
The stickler at Polygon will not be a happy chappy since the number of shares is not a rounded number. I expect more buying until they have a rounded holding for example something like 36,700,000. Never upset a stickler ... hahaha