We would love to hear your thoughts about our site and services, please take our survey here.
With due apologies the date of the Wade Lecture was released on 5th Jan at 1.41pm on twitter by University of Southampton..someone just found it 2 days ago and making a connection now. Let us move on. Last year Lecture was on 20th Jan
shorturl.at/akFNQ
https://www.beckershospitalreview.com/public-health/states-ranked-by-covid-19-hospitalization-rates-august-2.html
COVID-19 hospitalization rates: Jan. 3
Gabrielle Masson - Updated 7 hours ago
New daily COVID-19 hospitalization rates in the U.S. have risen 35 percent over the last two weeks, with 33 states and the District of Columbia seeing hospitalization rates trend upward, according to data tracked by The New York Times.
Data is taken from HHS and was last updated Jan. 3. States are listed in order of hospitalization rate percent increase over the last two weeks.
First CMC appointed around 1st week September
https://twitter.com/AIMdective/status/1436075314778673153?s=20
and second (additional) CMC ad came out November 1st/2nd week.
Credit to Detective AIM
https://www.sanger.ac.uk/news_item/rapid-immune-response-in-children-protects-them-from-covid-19-genetic-study-finds/
“Analysis showed that interferons were more strongly expressed in healthy children compared to adults, with a more rapid immune response to infection in children’s airways. This would help to restrict viral replication early on and give children an immediate advantage in preventing the virus from infecting the blood and other organs.”
Dr Kerstin MeyerWellcome Sanger Institute
In addition, there is growing evidence of the therapeutic benefits of inhaled interferon beta 1a. Based on the study results, this should be particularly the case for patients with weak or absent interferon activation.”
https://twitter.com/AIMdective/status/1475399244261507075?s=20
https://www.google.com/amp/s/amp.ft.com/content/74521753-c47a-4f1d-900f-8272f10e9305
Glenda has a smaller operations in Peru perhaps and hence did not take a small hit possibly
Thanks Matterhorn for clarification and adding good points to the discussion. Apologies don't frequent board often and missed that good informative post regarding test batches for regulatory approval from September.
Message 2 of 2
Don't think a placing is coming and no point getting scared of rumors. Synairgen is very well placed based on the definite hints company have got from the 2 trials so far with the recruitment of top guys last 4 months (for EUA, manufacturing, Clinical trials) who were ready to work for a current loss making minnow company. RM & Co are lining up ducks for EUA and full approval + COPD acute viral exacerbations P3 trial to start Jan/Feb possibly.
Market Makers and possibly hedge funds going short and trading below 0.5% like citadel who appeared only once on short tracker, have manipulated enough since May 2020 sucking in people with rises and drops thereafter, which have been significant. Initial one was when dosing news of first patient in Hull holding Philips nebuliser came on BBC on 4th May 2020 and it shot from 55p to 70p on heavy 12M volume and then dropped to 60p next day on 6M volume and in 2 further days dropped to 54p. Acacia was not in the selling scene then (till June).
Same happened with S,P3 last dosing news now on Thursday/Friday. Last dosing news rise will be temporary like any first dosing news of A2P3 as value above 175p hangs on top line results release in early Jan 2022 for SP to do a massive jump then. Market Makers have SNG on a tight leash till the Sprinter results land. Institutions buying big helps with sticky hands for SP to rise into the 200s. Opening price Thursday of lacklustre 188p was a hint. New investors flocked in midday with news spreading leading to rise. Shake the next day like on 4.5.2020. Patience needed if you believe in science behind synterferon and let results to do the final talking with Polygon leading the way for us. Best wishes to all SNG LTH.
Message 1 of 2
Quote of RM as per BBC article 20th July 2020 "He says he expects Synairgen to be able to deliver " **a few** 100,000" doses a month by the winter"
(Is this currently 200k or 300k in production we don't know)
Synairgen had production going for "Managed Access Program" from 29th Sept 2020 press release and we did not get much update on sales in annual report Sept 2021 and therefore there is enough of that Synterferon produced with good shelf life for few years stored at +2 to +8 degrees.
12th May 2021 interim report he stated "Investment in supply chain activities for SNG001 and the Aerogen aerosol delivery system have been made in preparation for launch.
Agreements signed with Akron Biotechnology for drug substance manufacture and Catalent Biologics for fill/finish.
In 20th Sept 2021 annual report states "Progression of commercial scale manufacturing processes for drug substance and drug product".
In financial highlights
"Research and development expenditure for the six months ended 30 June 2021 was £36.91 million as the Company advanced its Phase III clinical trial and **scaled up its manufacturing activities** "
£46 million cash in hand as of 30.06.2021.
Based on above there should be enough stock of SNG-001 produced so far and add another £10 to 20 million (out of 46) being spent to further scale up manufacturing with finish line in sight. Leaves £25M in hand. So what placing needed for what ????
The total treatment courses used so far perhaps was 300 + 50 for Sprinter + Activ 2P2 dosed patients. Add another 150 patients to that for drop out patients. Total 500 x14 doses = 7000 doses. Remaining 50% patients were placebo and needed saline water syringes.
So over 12 months @ rate of "few 100,000 doses" has SNG not produced enough doses conservatively say from January 2021 (let us assume till Dec2021) - 100,000 doses/ month x 12 months = 1.2 million treatment doses stockpiled ?
This is about 85,000 treatment courses (or twice or thrice of this extrapolating "few") they can hand over to US govt on EUA from the SNG store. Please correct me if I have this bit wrong regarding treatment 14 day course vs treatment doses.
$3000 per treatment course approx in USA if you look from revenue point of view with 85000 treatment courses ready for supply ;) Jan 2022. Leave calculations to ye all. So what placing needed for what ????
RM stated in Sept about Govts support to scale up production higher (with supply chain help) if demand was high across board as they are restricted to ? around 15,000 - 14 day treatment course maufacture per month which sounds very small looking at worldwide need.
RM was looking at blowseal technology to overcome glass ampoules shortage going forward. Who knows US govt might have given a few million $ assistance for production for A2P3 doses (and advance booking of supply) considering they realise we are a small UK company, when big pharmas got grants and perhaps SNG don't have to
https://www.bmj.com/content/375/bmj.n2635
Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports
........ ........ ......
Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November.
Nice to see good dividend land in the accounts today from CAML. 2nd 8p dividend this year. Picked up some Glenda with that.
Hope you regulars on board keeping well and seeing portfolio improve.
Looks like the extra dose of 0.8MIU does help when given to all patients in trial ! Explanation below.
In UK phase 2 after lot of cross checking I note they used the Philips Ineb nebuliser with the lower dose but higher delivery efficacy to lungs of SNG with one syringe only leading to 3.8MIU reaching lungs.
They also used Aerogen Ultra with 2 syringes but lower lung deliver efficiency, but final dose into lung was 2.3MIU x 2= 4.6MIU.
There was never breakdown in P2 study about difference between Philips I neb or Aerogen. Same in home trial looks like both devices were used.
Numbers were small though then.
Activ2 and FDA for Sprinter then said to go ahead with Aerogen Ultra 2 syringe dose only (Higher dose). If Activ 2 showed benefit then the question is did the slightly higher dose of 21% via Aerogen make additional difference in activ 2 over P2 UK home trial?? Personally think so. Slightly higher dose in 100 patients A2P2 passed the safety also.
It is possible the recovery and putting out covid fire in hospitalised patients will be better with the higher dose. 2 months or so to get the verdict.
Views from other welcome.
Regarding Sprinter 3 many would say 95 to 99% chance getting good results, EUA and regulatory approval for full use thereafter. Need for multiple treatments directed still there with rising cases and mutations next year also. US Activ trial looking at multiple treatment options not to be caught off guard if things worsens or mutations make current approved EUA drugs ineffective.
COPD viral exacerbations use Phase 3 trial thereafter will be easier as safety and dose already cleared. Trial run of big P3 done. The big market of COPD viral infection treatment and attraction for big pharma lies there. Sprinter P3 is a stepping stone to bigger health benefit for patients and investors.
Correction currently using 24MIU via 2 vials (0.63 ml each vial contains 12MIU) .
Dose emitted by Aerogen Ultra being 14.3MIU of the 24MIU with dose going into lung 5MIU (0.42ml) based on 34.9% efficiency of Aerogen Ultra.
https://www.bbc.co.uk/news/health-58170809
Ivermectin has been called a Covid "miracle" drug, championed by vaccine opponents, and recommended by health authorities in some countries. But the BBC can reveal there are serious errors in a number of key studies that the drug's promoters rely on.
Read pages 216 to 221 which covers safety profile over numerous study. Overall safe with no serious adverse effect upto 12MIU administered dose currently being used.
https://fnih.org/sites/default/files/2021-04/Protocol%20ACTIV-2-A5401%20Version%204%20dated%2031March2021_0.pdf
In a segment where they were discussing about the Merck Miracle covid pill they cautioned about the need for many such different pills as previous experience with HIV virus had shown the virus mutates to develop resistance to a single pill.
Fauci said there was need for different treatments for different aspects of the covid infection and need to build up an armament of treatments for mutations. Therefore Synairgen if safe based on safety data and shows evidence of even marginal benefit based on all data provided including the UK P2 data + invitro lab data to the activ 2 panel will get the go ahead to P3. Activ2 panelists have agreed to look at all data as they want good drugs from P2 with decent chance to progress to be looked at as there is dire need for oral + inhaled treatment to act synergistically. They will have an arm in P3 looking at combination drugs too like in HIV trials in the past.
Ha ha....same thought came to about Mario's uncomfortable spectacles which editing the video clip
Download the less than 5mb file and play it as it does not play well directly from Google drive.
https://drive.google.com/file/d/1CRUzUa8Fa7T_MRlSkdZQJ5_cPvzNKXwz/view?usp=drivesdk
For those who want to cut to the chase about what Mario really said.
Hope this helps.
https://drive.google.com/file/d/1CQ6hf2JGhQNnetV3JZCk8WO7S1euZlFx/view?usp=drivesdk