The next focusIR Investor Webinar takes places on 14th May with guest speakers from Blue Whale Growth Fund, Taseko Mines, Kavango Resources and CQS Natural Resources fund. Please register here.
Ndn71 - No one wants a battle, it's not what the BB is for. The issue is you either unknowingly or knowingly turn it into a 'battle' by instead of learning from, engaging with and/or asking further questions to clarify a point(s) when a poster corrects you or trying to guide you; you instead revert with further statements defending your point(s) when you clearly have not got it (all) right and where it seems you have not given the poster's comments any serious thought.
This is not the manner to go about conversing when the aim is to learn. When you receive a genuine response remember that, that person has made an effort to provide a genuine response therefore it should be received in a respectful manner.
You guys miss a fundamental point. Your argument assumes infinite time and resources to run clinical trials and (in a way) assumes failure of SG018. You may not mean the latter, but that’s the consequence of your argument. Also, that assumption (infinite time and resources) does not exist.
When you design a trial you use prior data to identify the cohort of patients based upon which your drug has the highest probably of being proven successful. If your trial is successful then that is the group of patients which qualify for treatment with your drug. No pharma would, after producing positive results, not apply for Regulatory approval and instead continue to do trials to further refine the cohort. At which point do you then stop? Waste more money to achieve perfection and in the mean time deny patients treatment.
Now, you may argue they won’t need to do a further trial due to the results of the subgroup. Well, the problem is the subgroup’s results may not be statistically significant and would require a new phase III trial. That would definitely be the case for SG018 due to the low number of patients in this trial.
Future treatment advice may change as a result of data gathered through pharmacovigilance.
A number of subgroup analyses will be performed for SG018 as per the protocol.
‘Understanding Rhinovirus Circulation and Impact on Illness’, published yesterday, relates more to SNG’s COPD aspirations, but it shows how challenging an environment respiratory viruses are when it comes to developing treatments and/or vaccines.
https://www.mdpi.com/1999-4915/14/1/141/htm
‘RVs are now established as a major cause of respiratory illnesses, and its most severe clinical presentations may not only be substantial, but also more costly than other common respiratory viral diseases including influenza or respiratory syncytial virus (RSV) [3–5]’
Fun fact. There are three types of rhinovirus and 169 subtypes.
Here are a few quotes describing these challenges:
[re vaccines] ‘Unfortunately, the lack of cross reactivity between RV subtypes hindered progress and underlined RV antigenic diversity as the major challenge for vaccine development [67–69].’
‘Amongst early antiviral strategies, virus targeting capsid-binding drugs (Pleconaril, Pirodavir, Vapendavir) showed efficacy on preventing virus entry [78,79], but posed issues of rapidly emerging drug resistance [80–82].’
‘Early research tested the prevention of severe RV symptoms by prophylactic intranasal alpha 2 IFN treatment. Treatment did reduce virus induced symptoms, however this was offset by IFN-induced nasal inflammation [90].’
‘Inhaled nebulized IFN-ß was tested in an asthmatic cohort to determine if it can prevent viral exacerbations. Despite not reaching its primary endpoint, this research showed the potential of modulating innate immune responses in susceptible populations [91].’
‘Recently, use of nebulized IFN-ß for the treatment of hospitalized COVID-19 patients showed clinical benefit by reducing the risk of progressing to severe disease [92].’
It's not from Fox news. Copy and paste job with questionable research including inaccuracies.
Welsh - totally agree. They would severely damage their reputation if they act as a middle man and not maximise profits for their clients.
HSD - that would also not happen. They invest clients’ money and so have a duty to maximise profit. Again this would be damaging to their reputation.
Why starting a new thread when there’s already one???!!!! I see this every day. Mind bloody boggling.
Polygon would not be buying on someone else’s behalf. It’s not what they do.
Polygon and Woodford may have had a few boozy lunches :-)
Initially prior covid vaccination was part of the exclusion criteria. However, while conducting the trial investigators/company noticed a number of vaccinatied patients requiring oxygen treatment.
Based on this they amended the protocol to include those previously vaccinated. This was done around Apr/May.
While on the topic of ACTIV-2 here’s yesterday’s testimony before the Senate Committee for Health, …. Just a mention really.
https://www.help.senate.gov/imo/media/doc/Fauci12.pdf
Activ-2 enrolment closed for BMS-986414 and BMS-986413 developed by a partnership between Rockefeller University and Bristol Myers Squibb.
So they must’ve failed phase II.
https://www.nih.gov/research-training/medical-research-initiatives/activ/covid-19-therapeutics-prioritized-testing-clinical-trials#activ2
That’s a dangerous rationale upon which to base an investment decision.
You only have to read ‘The Greatest Trade Ever: How One Man Bet Against the Markets and Made $20 Billion’ to know why.
Brysoa - thank you.
The standard normal table is coming back to haunt me. How I hated stats at uni :-)
Brysoa - a few questions if I may.
1) How do you get to 0.92?
2) With specific reference to the very last sentence of the below paragraph from the protocol. How does this link with your 0.92? Am I right that this sentence mean the futility analysis is based on 95% power?
'Success will be determined if at least one of the primary endpoints is declared statistically significant by the primary analysis. A sample size of 610 patients in total using a 1:1 randomisation ratio (305 patients per treatment arm) has been chosen to provide at least 90% power to detect a hazard ratio of 1.45 in time to hospital discharge and a hazard ratio of
1.7 in time to recovery and at least 95% power to declare statistical significance on at least one of the primary endpoints. This sample size has been calculated using a global 2-sided alpha level of 0.05 and allows for an interim analysis to assess futility.'
B2HS2L - I hope so too. It's only prudent to be conservative, or at least to try, and not to interpret the RNS as inferring success, however I accept it's difficult not to think otherwise.
Many have asked about the timing of and reason for the announcement and in my view it was all part of getting everything ready and in place for launch. Ashfield would need time to put in place the necessary 'infrastructure' so that once an EUA is granted (hopefully) they can hit the ground running, even before then. This announcement not only gives them the authorisation to proceed with their preparations, but also free them from doing so in secrecy. It's also a clever bit of unofficial marketing by Synairgen.
Please can we not go down this topic again. It’s a topic with a number of nuances and complexities which are not suited for social media discussion.
Instead go out and enjoy the beautiful sunny day with your family and/or friends - go support your local hospitality venue which so desperately need your custom. You/we are not needed here.
Happy Sunday.
This interview suggests phase III is underway. I shared it back in Dec.
https://youtu.be/G803aMK1xy0
I do not expect, nor is there a need for an RNS to announce first patient dosed in phase III since it was already covered by the 15 Feb 2021 RNS. You’ll notice it does not refer to phase II only, but either to ‘ACTIV-2’ or ‘ACTIV-2 phase II/III’.
Recruitment completed on 10 Nov.
I wonder whether the Ashfield partnership was the catalyst for setting up Synairgen Research (Ireland) Ltd. If so this deal has been on the cards for many many months. It could of course just be a ‘co-incidence’.
The wording of the submitted and pending covid patents have not been made public nor have they been approved. As such your statement is premature and potentially partly false. Not that I see any reason for the patent application to be rejected. We do however have ‘protection’ until it’s approved
The patent application would refer to IFN beta administered via inhalation plus some other criteria. It could be specific in referring to IFN beta 1a or to IFN beta in general as is the case with the influenza patent.
We most definitely have NOT patented inhalation by itself irrespective of the agent. It wouldn’t be possible to patent.
The patent would refer to the use of SNG001 as a therapeutic in the hospital setting and most probably in the home setting too, but there is no guarantee that it will cover prophylaxis use.