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If you are not sure how ACTIV-2 works then go read the protocol and stop speculating!
Progression to phase III will be decided by the Trial Oversight Committee and the company's management. That is a fact.
As some has said the company is not in a position to discuss details about the trial unless being given approval by the NIAID. Again this is a fact.
Fruitsnveg - with regard to ‘a few years’ I was referring to future pandemic preparedness, not seasonal respiratory illness preparedness which would include covid-19, as that’s what the question was.
Agree with you that seasonal demand will be there in the years to come. Manufacturing for that in 2022 specifically was covered in the latter part of my answer. Also, I was coming from a worst case scenario when answering the question.
nav21 - I hope the BOD was not bullied into explaining the delay and instead was forthcoming out of own will. When sales of about £800m to £1bn (£200m p/month), based on 2021 forecasted numbers, are lost due to delays in completing the trial you should without a doubt proactively provide an explanation to your shareholders. The explanation was light touch and I would’ve preferred had they mentioned exactly what actions are being taken to speed up recruitment. Maybe a change in strategy was/is required for example activation of dormant sites while reducing numbers to be recruited in some countries. I know they said they’re still adding sites, but this takes time.
What’s done is done. We can only hope for the ultimate best now.
Prion25 - I remember yes, but didn’t pay attention or saw the need to get excited about it since it was not discussed in the context of a specific program of which a Synairgen was part of.
stu485 - let’s assume the data will be good. Production is simply a question of demand. No demand means no production. At present Synairgen’s target client is governments.
If covid is not an issue by the time we have results Governments may not issue an EUA which in turn will result in no orders and no production.
Re future stockpiling for pandemic preparedness - this is totally dependent on Governments first wanting SNG001 and secondly depends on when they might order it. Could be in a few years’ time. So not necessarily next year.
Despite the above worst case scenarios we’ll have some sales at least which will come from the batches we’ve produced in 2021. If sales exceed available stock levels we’ll manufacture.
You then need to look at funding too. To manufacture they’ll need funding and they won’t get funding if they can’t show signed sales agreements.
RM is being prudent in his wording which is the responsible thing to do.
Doc - I was hoping that the company would consider an interim readout should the data support such a move based on the interim analysis, of which the primary purpose was to determine whether the trial should proceed or not, but after listening to the Proactive interview it seems that RM/company is definitely not entertaining such an idea. My hope for such a move was based on commercial reasons purely.
I saw a few comments questioning SG018’s seemingly slow recruitment so thought I’ll put this out there.
SG018’s protocol was approved on 21 Dec 2020 with most of the trial applications submitted to the various countries’ health authorities during Feb 2021. Some maybe a bit later.
Slow progress is not necessarily due to slow recruitment, but rather due to the various countries’ health authorities, in the context of a pandemic, dragging their feet with the protocol and trial approval. Refer to the below timelines as to when each country provided the final go-ahead, note this does not necessarily mean recruitment started during that month.
We need to be grateful for the UK health authorities’ support, speed and efficiency. As at the end of Apr 2021 about 100 patients were recruited in the UK whereas in the rest of the world that number was basically zero.
The data below is from slide 24 of the presentation – the recruitment numbers per month are an estimate based on the graph. Countries listed next to each month denotes when the final go-ahead was received.
Few points to note:
- I’m a bit baffled that we only have 5 sites in the US which seems to be our ‘main’ market
- Argentina gave ethics approval in Jun, yet final approval given in Sep. [As an example]
- I’m of the opinion that not all of our 100 plus sites are still recruiting. If that was the case you’d seen much higher numbers in Aug & Sep.
Jan: 27 - UK
Feb: 40 - US
Mar: 29 - Israel
Apr: 7 - France, Belgium, Portugal
May: 50 - Italy, Brazil, Spain, NL, Serbia
Jun: 53 - Columbia, India
Jul: 88 - Romania
Aug: 100 - Mexico, Germany
Sep: 80 - Argentina
Correct. From the Proactive interview it was clear that they would use a full SG018 data set for the EUA application so we're looking at early 2022. I have to admit I'm somewhat disappointed in that I was hoping that interim data would be considered, if sufficient, to do an EUA application to offset at least in part the lost sales due to the delay. Again, provided the data supported such a move. It's potentially a significant amount of revenue we'll be missing out on.
sparkyboy1 - we passed the ACTIV-2 interim analysis. Now just for the final hurdle. Refer to my previous post.
The-Lockie - refer to my previous post.
Here's what happens with ACTIV-2 phase II once the trial is filled:
- 28 day period to collect primary end point data
- Analysis of unblinded data by the DSMB
- DSMB provides the NIAID, trial sponsor, with their recommendation as to whether the agent needs to proceed or not
- NIAID reports the data/recommendation received from the DSMB to the TOC (trial oversight committee)
- The TOC together with the company's mgmt will make the final decision.
All in all it takes about 8 - 9 weeks so we're looking to hear within the next two weeks.
Joey - the ISRCTN suggested a Dec 2021 top line readout. Recruitment completion 01 Oct and primary completion date (note they classified it as ‘Overall trial end date’) of 05 Nov so that gives sufficient time for top line read out in Dec.
Commercialisation is what caught my eye. First time they're using it.
I’ll guard myself from reading too much into this, although I do find the change interesting or perhaps reassuring to an extend.
From the last RNS take note of the replacement introductory paragraph of the ‘About Synairgen’ section which is found at the bottom of each RNSs.
New paragraph:
Synairgen is a UK-based respiratory biotechnology company focused on drug discovery, development and commercialisation.
Previous paragraph:
Synairgen is a clinical-stage respiratory drug discovery and development company founded by University of Southampton Professors Sir Stephen Holgate, Donna Davies and Ratko Djukanovic.
*definitively
HelloSanDiego - no one can definitely answer your question. However, based on timelines it’s highly likely they would have seen the unblinded data by now. We may get more clarity on Thursday.
gunto2020 - An EUA and regulatory approval are two different things. RM’s quote, if interpreted on face value, refers to regulatory approval.
For example vaccines have been administered based on EUA while approvals were outstanding.
If memory serves me right a member of the board asked this very question to Synairgen of which the response was shared here. Unfortunately I cannot remember who it was or when exacty. It was in Q4 2020 sometime.
Hopefully someone who remembers or the member sees this.
Just read up on the various components. Both the Aerogen Ultra and Solo are for single patient use only. The Pro X Controller is for re-use and has a 2 year warranty against manufacturing defects.
breatheasy - thanks for pointing out the Pro X controller something not discussed before which is actually so obvious. Pretty steep in price.
I assume the Pro X controller, solo & ultra are sent back to the hospital after being used by the patient where it’s recycled back into the system for use. That’s after being sterilised and tested again. Maybe those members who were part of the SG016HOME trial can answer the question. Doing this can reduce the costs.
Peelweight - the dates as per the protocols are a bit of a shambles. The individual(s) responsible for updating them don’t seem to be a bright spark.
Recruitment end date is predicted to be 01 Oct.