Cobus Loots, CEO of Pan African Resources, on delivering sector-leading returns for shareholders. Watch the video here.
I thought I'd just throw some dates out and get views, to try to give an idea of how quickly SNG001 might be used in the mainstream, assuming efficacy proven. This doesn't cover the possibility that authority is given independent of the phase 3 trial.
Best / accelerated case:
IND application end October
Phase 3 trial begins / recruitment starts end November
Interim results end January
EUA mid February
Mainstream usage end Feb / early March.
Any thoughts?
Bets if somebody else confirms, but I think we've been round the loop on this "worry" about the Amiens study and I recall the Synairgen patent was for Beta-1a, and Amiens is Beta-1b, so there is no patent issue. And I believe there is research to suggest 1a would be most effective.
But helpful if somebody with the links confirms this.
Leaf, did you see the risk register on the open offer letter? You were asking about risks a while ago, and it looked like a pretty comprehensive list to me, presumably put together either internally or by their brokers.
I know he's not been great previously but I saw a man struggling today. Particularly when asked why they aren't taking stronger decisions when 10s of thousands of people are being infected every day. He looked like he was close to breaking.
Not good, but in my eyes the government are increasingly irrelevant to the future of SNG.
I’d suggest discussion on risks is not terrible but is best left for the weekend if you genuinely want to discuss it.
What I’ll say for now is that it’s been a lively few days to say the least but to put it simply we now have a clear view of RM’s plan going forward where as little as a few days ago we did not. I’m just completely comfortable to sit on my shareholding now for the long term and really couldn’t care less about day by day fluctuations.
Good luck to everyone.
In reference to Regeneron he said something like it had shown positive results in 1 study, not in 2 studies, and that it's completely unproven as yet, and has serious side effects. Implied from me, he would be very much against any form of emergency use.
Seems a shame that a lot of the questions for such a specialised expert are so generic around vaccines and transmission. I've asked a few treatment specific and nothing asked yet.
Can it be used preventatively? "Quite possibly, yes."
I read somewhere that they're virtual for the foreseeable future, can't recall where exactly, but for sure on the EMA website.
I haven't seen anybody make this point, but given that the required funds were already set internal to Syn, the higher the price the better given that it leads to less dilution of the existing shares. I'm glad we weren't at £1.40, we'd have been looking at far more shares placed.
Thanks :)
I'm totally sold, this has precedent:
https://www.youtube.com/watch?v=A4I9DMSvJxg
They should probably rename this to "Up 41% since Friday here's some outdated and largely irrelevant information but hey it keeps me busy"
I bought yesterday at 234.5. How do you like them apples?
I read this as a statement that the principal researcher of the study had received consultancy fees from Synairgen - stated to ensure any potential conflicts of interest are made clear.
3 tiers in the UK.
PM saying he won't force regions into top tier.
Regions saying they won't accept top tier without control of test and trace, and financial support for employees.
CMO saying top tier basic restrictions not enough to stop spread without additional measures in any case.
It's going to be a long, hard winter.
On availability, it certainly (and sensibly) looks like a key part of the emergency use criteria:
What is needed for a formal EUA request?
The FDA recommends that Sponsors include a well-organized summary of as much of the following as possible when applying for an EUA:
A description of the product and intended use
A description of the product’s FDA approval status
Efficacy and safety information, including data from any clinical studies and nonclinical in vivo and in vitro data: The threat posed and the nature of the product determine how comprehensive the evidence for EUA issuance needs to be. However, the requirements are typically less stringent than those for product approvals. The FDA considers a number of factors, including whether the product has already been approved for another indication and, if unapproved, its stage of development.
An analysis of the risks and benefits, including any measures taken to mitigate risk or optimize benefit, any contraindications, and any gaps in data
Information on the chemistry, manufacturing, and controls of your product: The request must demonstrate final product availability and the manufacturing sites’ surge capabilities. Notably, certain current Good Manufacturing Practice requirements may be waived for EUAs to accommodate emergency response needs.
Information on any available and approved alternatives to your product
A fact sheet providing information on dosing, contraindications, warnings, and adverse events for distribution to health care workers and authorized dispensers of your product
WedME thanks for the responses. Quite important that we don't all just start chucking every medical question we have at you. Sounds like you need your sleep!
Kind of related to your point on building use with steroids into further trial efforts, it occurred to me last night that it would be really interesting to start to see some new combination trials started - for example SNG and monoclonal antibodies. You might for example be able to achieve much better results with smaller quantities of the monoclonal antibodies, given that manufacturing such volumes is a problem for that approach - e.g. SNG and 2g regeneron rather than 8g.
Fairly random thought, but I guess my general observation is that we'll start to see a new phase of trials with combinations of successfully trialed drugs, perhaps in the new year.
WedME great posts, really informative thank you. I have a couple of points / partial questions.
Use with steroids - I know that the COPD trial results indicated that SNG001 could be used with steroids, but recall that it was based on a subset of the trial patients that were receiving SNG001, from memory 19 (excuse my Sunday morning laziness if I have the wrong number)? It strikes me that given the numbers, and the importance of working with dexamethasone, this particular circumstance would need to be further tested. Do you have a view on how they might go about this? I'd hope it wouldn't require an additional clinical trial, but at the very least its an area that would need to be trodden very carefully?
My second point is probably less of a question, but I'd still be interested in your perspective. It relates to the side effects driven by other delivery methods of Interferon beta-1a. Regulators and clinicians are bound to be fairly cautious around the use of interferon beta-1a because of these other studies. It leads me to conclude that the question of emergency approval around SNG001 is a tricky one, having to consider not only the positives - the strength of the trial results and all the supporting science around the theory of why it would be an ideal treatment for covid, but tempered against the other delivery-method side effects, and the small scale of the clinical trial. This is why on some days I'm convinced emergency use will be granted and on others I think a larger trial will be needed. Do you have any thoughts on this?
Weekends are good for these kinds of discussions I think as it distances people away from the emotion of the rising and falling share price.
I love that you listened to this for 30+ minutes not understanding a word, listening out for Synairgen :)