Member Info for Patience001

...a thing of beauty......

It could fall under ID or AI/I , so either way - odds look good

The Polar Biotech fund stands alongside the Worldwide Healthcare Trust in terms of performance - based on experience

His prounounciation of monoclonal antibodies was that of someone who didn't know what he was talking about!

Shan - looks like it modulates inflammation in ARDS patients. A different treatment pathway but none the less one of the many treatments required for COVID.

I've never seen a pattern of trading like today on this share. Its a sea of sells at a very controlled price!

MrCosts - If you understand anything about pharmaceutical development you should be aware that many of our breakthrough medicines have surprisingly sat in vast development libraries for years before eventually making it.....

Pmjh - I believe based on the FDA response and the following "On 14 October 2020 the Company was informed by the National Institute for Health Research (NIHR) that the Phase III trial has been badged in the UK as Urgent Public Health and will be recognised as a National Priority study. Notwithstanding this, the commencement of the trial will still be subject to normal regulatory and ethical approvals" - EMA decision making must be straight forward....indeed assuming it is on the list!

Given the commercial sensitivity of such a decision, I believe both the EMA and the owner are keen to communicate asap. A delay presents the probability of a leakage which neither party wants to have to deal with.

Based on the size of the Phase III CT with international centres, I don't see this being very long and likely could be looking at commercially available product Jan/Feb. It will be interesting to see if the 'on-going' discussions with EMA , will be concluded tomorrow with a PRIME designation for SNG 001....

Excellent news on so many fronts. All key Regulatory Authorities now aligned led by FDA. Confidence is reflected in the calibre of experienced partners which are now onboard, Parexel as CRO, 2 experienced Manufacturers for both the active substance and secondary fill & finish. I'm genuinely impressed that the team at Synairgen has achieved the alignment of all of this since July.

..i meant to insert the link

https://www.novartis.com/news/media-releases/novartis-received-european-medicines-agency-ema-prime-designation-iptacopan-lnp-c3-glomerulopathy-c3g

@pmjh, Novartis received European Medicines Agency (EMA) PRIME designation for iptacopan (LNP) in C3 glomerulopathy (C3G) which was announced on the 9th Oct 2020. This suggests that decisions are not confined to the scheduled meeting.

TlWilliams - you are correct indeed! I'm an AIM/Life Sciences investor since 2008 having worked in the sector for 3 decades! Like most serious investors in synairgen I've grown weary of the surprising lack of understanding of the fundamentals by some posters. A golden rule, which has served me well - invest in things you understand, not only is it good for your wealth....also your mental well being!

pmjh - I particularly value your posts and shared intelligence however a correction to your post - 'she'.....lol

MrCosts - the pathway to medicinal product development is such that patient safety has to be the priority. Investors needs don't register with those who are involved in the authorisation of products! The timelines will be dictated by the regulators and will be driven by the 'completeness' of the FULL dataset required by them to make the right decisions. I would also add as it is a factor that the synairgen team will be dealing with upscaling and expanding the manufacturing capacity to meet launch and commercial needs is not merely a matter of building the manufacturing process, they have to complete a lot of process and product validations etc etc.... So, as RM has stated patience is necessary, the science is good