The latest Investing Matters Podcast episode featuring financial educator and author Jared Dillian has been released. Listen here.
SNG001 will be a prescribed medicine. I do not see it being an OTC drug at a pharmacy - somewhat of a farfetched idea that.
It’s naive to think they’ll provide market sensitive information.
dactions - my scepticism refers specifically to the comment and not as to whether Synairgen attended or not. That may not have been clear from my post.
I don’t doubt Synairgen’s attendance (and would not be surprised if they were there since they’ve been ‘close’ to the EMA). It is after all a networking event/opportunity so I would expect them to be there, should circumstances allow, irrespective of the fact that they would’ve known who to contact.
I’m a bit sceptical.
I find the following sentence not referring to Synairgen for two reasons.
‘… we will have to consider an accelerated procedure for the registration of the product and the devices. We now know the contact persons to move in this direction.”
1) Do you want to tell me Synairgen have not considered accelerated registration and had not known who to contact? They’ve been working with the EMA since last year so surely they knew how to go about.
2) With reference to ‘registration of devices’. The Aerogen nebuliser is already used in hospitals so it does not need registration. Unless it requires specific registration with SNG001. I also find it odd that RM would speak of ‘product and devices’. I’d say he’d rather just speak of ‘product’.
The article does not state 1st October as the starting date. It only says ‘starts in Oct’.
Once the decision has been made to progress SNG001 to phase III an RNS will be issued. That decision hasn’t been made yet.
Fruitsnveg - if I may. The line of thinking that the company is setting itself up for may it independence, licencing, T/O, etc is not correct.
Instead, it’s a case of Synairgen growing organically where the needs of organic growth and the speed of it are dictated by the development of their drug and the commercialisation thereof. Part of this will require outsourcing of some activities which we’ve already seen. (A company doing this have a higher chance of being successful and maximises shareholder wealth.)
Secondary to this you may have licencing or a take over of sale of Synairgen Research Limited.
Slightly different way of looking at ‘independence’.
On what is the 'delay' hypothesis based? No evidence of that unless someone has got hard facts. If you look at Camostat the decision to remove it from ACTIV-2 was made seven weeks post trial recruitment concluded and another two weeks until the announcement. We could be close to the DSMB ( Data and Safety Monitoring Board) decision.
Peelweight - The Q&A will be live exactly how it was for the AGM.
Peelweight - as was the case with the AGM I suspect the details of the webinar will be published on the company’s website about 72 hrs prior to it happening.
theboyg - it’s to allow the investment community incl analysts to diarise the investors’ call.
*referred to
Synairgen haven’t conducted animal preclinal studies as far as I know - the biotech they referred have.
HelloSanDiego - you referenced 1 million and then said you’re not sure whether it’s doses or treatments. The only time when 1 million was mentioned without reference to doses or treatments was in the MRC animation from a few weeks back so I automatically thought that is what you’re referring to. It was confirmed by Prof Sir Holgate via the MRC that the 1 million referred to doses and that would be per month.
dunk1973 - I believe the MRC animation used 1 million because it’s a nice rounded figure. The company forecasts were to be ready to produce 100k treatments per month. Doesn’t matter whether it’s 70k or 100k per month Synairgen will be ready to produce the goods. They’ve done the ground work.
1m doses. Not treatments.
I did some further research on this including the updated document provided by Ndn71.
Batch size:
Both the EMA and FDA have a 10% rule meaning the validation batch size should be at least 10% of the commercial production batch size. Based on RM’s comments of 100k treatments per month that would equate to 10k treatments or 140k doses. (I’m ignoring the 100k validation batch size (measured in doses) as that’s less than what RM alluded to and the Regulatory requirement states ‘greater of 10% or 100k)’.
Number of batches:
In my earlier post I mentioned three batches, but that’s based on old (FDA) language. The FDA does not specify the minimum number of batches while the EMA seems to require data on a minimum of three batches. The number of validation batches will be dictated by the required confidence level while achieving statistical significance.
Manufacturing partners & combinations:
We know Akron and Catalent are part of the supply chain. Based on the Investors Chronicle article we have Thermo Fisher on board for fill finish and seem to be retaining the relationship with Rentschler. Are we testing each of these combinations? Probably not, but I guess we would at least test a combination of Akron & Catalent and Akron & Thermo Fisher. I might be wrong on the latter – just have a hunch TF was brought in as a result of ACTIV-2 and so it would need to be tested
For simplicity I assume commercial scale batch would equal that of a month’s production i.e. 100k treatments. As to how much have we manufactured - good question - if this assumption is correct probably about 30k treatments. Could be wrong.
Fruitsnveg – re ACTIV-2, I remember looking at it earlier this year and as part of the application process Synairgen had to provide evidence that it can successfully upscale production. I have not seen anything to suggest batch validation procedures have been amended specifically for ACTIV.
Thx for your input Fruitsnveg & Ndn71.
Disclaimer: 1) This aims to address the question on potential current production levels as part of the supply chain validation process and not future commercial production.
Page 17 section V(A)(1) https://www.fda.gov/media/70949/download
Pages 5/6 section 5.1 https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-process-validation-finished-products-information-data-be-provided-regulatory-submissions_en.pdf
https://www.investorschronicle.co.uk/news/2021/01/14/with-vaccine-roll-outs-underway-what-does-the-future-hold-for-covid-19-treatment/
Fruitsnveg - that’s brilliant. Thx!
In addition it seems you need to produce at least three batches as part of the validation process. That means in a best case scenario we could be looking at 300k doses manufactured which is roughly 21.5k treatments.
Doc - the animation didn’t say whether it was per month, but RM stated 100k treatments per month. Numis’ broker note was also based on 100k per month. It would be right to conclude that’s what the animation was referring to.
The MRC animation stated 1m doses which equals about 71.5k treatments per month.
The reference I made to RM’s comment which was ‘done to validate commercial scale’ could give an indication as to potentially how much product they may have produced. As I mentioned, it’s open for interpretation. What’s worth bearing in mind is that, if it’s their aim to manufacture circa 1m doses per month then the question would be how much (i.e. doses) should they produce as part of a test run or runs to give them a sufficient level of confidence that they can pull off 1m doses per month. I don’t know the answer to that, although I would think it has to be a fair bit.
Of course we won’t have huge quantities and we shouldn’t have yet, but what I was trying to convey is that I’d say or think that we have a decent amount of product on the shelf already.
Doc - you’re right I didn’t add that very last sentence, but it was deliberate. I wanted to focus on manufacturing done as part of process validation and the potential quantities produced as a result.
Part of the process validation will be the fill & finish by Catalent. So maybe someone with manufacturing experience could share with us what they think the minimum quantities required by Catalent would be to do a such a test run(s).
Manufacturing featured quite a bit over the past day or so. The best way to address the topic would be to refer to Richard’s comments during the AGM's Q&A session back in June. That is of course in the absence of the soon to be released interim results.
Forward to 11.50 of the video
https://www.lsegissuerservices.com/spark/Synairgen/events/1cd87eb6-5e01-4e1a-b3bd-f8288bbb6b5b
This is what RM said:
- They have manufactured multiple drug substance batches i.e. interferon beta; and
- several drug product batches which are now undergoing stability studies.
- This is done to validate commercial scale end to end manufacturing process.
The last bit of the answer ‘validate commercial scale’ is potentially open for interpretation. Does it mean …
1) they are producing (a one off) at commercial scale to test the manufacturing process or
2) it’s not at commercial scale, but (much) smaller batches to ensure commercial scale would be possible?
Either way it would not be wrong to deduce from this that there are potentially quite a bit of drug sitting the shelve ready for distribution. I would be particularly keen on knowing to what extend Thermo Fisher is involved which was referenced in an interview by Investors Chronicle in Jan 2021. This is the only time the company mentioned TF's involvement. Is it maybe linked to ACTIV-2 on request of the US Gov, hence no word about it.