The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
Phase III primarily is to confirm safety and then compare to other drugs on market. Given the fact this drug illicits a natural protein to be created and is PH neutral and then the opposition!. There really isn’t very much to compare it too. So why kick the can down the road three months when given the choice I would take if today no problem at all if I had Covid.
Scientists will make the decision and hopefully what’s right by the affected patients will suffice. I don’t however believe RM is talking to EUA, FDA and MHA about phase III trials. As far as I’m aware Remdisivir was allowed to market with less efficacy and a lower quality trial than SNG016. So what gives?
It would be a brave call to make SNG go through a phase III Trial with potentially 10’000’s of people dying this coming winter. Given the patients in the Asthma, Covid and COPD trials can give weight to safety along with the fact the same treatment in injected form has been taken for years in MS. That leaves efficacy. Covid and COPD trials and the Asthma patients who had a cold/flu can lend weight to that. My feeling is they are waiting on the COPD data to support the above. If all that is positive I would be very disappointed if this isn’t given expedited approvals. Especially given the speed they allowed Remdisivir to come to market. And that isn’t as good as our drug.
The people that have lost parents/family members because of that decision are already looking for answers Algy. The answers to who knew what and when will come out then I hope. The preliminary report the other day stated care homes were treated abysmally in this scenario. Let’s see what happens, but I think we agree to disagree.
TILS are some way behind in their phase testing yes. Nolupus would be better placed than me to comment but I believe the IL6 Inhibitor treatment is more geared to tackle inflammation, which is a more later stage Covid condition. Not a TILS holder sadly so would need that clarified :). I did consider them when they were 70p though:(.
No I certainly haven’t lost faith in fellow humans at all. To think doctors or whoever made those decisions cannot make mistakes is a mistake too though. It is very difficult to prove negligence against medical professionals in any case as the standard of proof is raised for them. Simply because you didn’t ‘intend’ for something to happen Should not then permit you to carry out an action carte blanche without any heed to the consequences. If that were the case crimes like manslaughter would not exist. ‘Intention’ doesn’t need to be satisfied there at all just the ‘act’. Similar to killing someone on the road. No one, ordinarily, intends to do it but by your actions you can still be charged with manslaughter.
Algy- I really hope the people who made those decisions don’t get off with ‘we didn’t know, only with hindsight’. Ignorance is no excuse in the law. I’m no medical expert but I was saying to people in January, knowing what we knew then, i.e. that the elderly were most susceptible to the virus that if this got into care homes we were in big trouble. All the evidence from China and Italy, particularly Bergamot pointed to that. For the powers that be to then decide to send older people that had Covid back from hospitals into the care home setting, in many cases without testing to see if they were still a danger to others was completely unforgivable. I don’t doubt infection came in others ways too but that is an awful decision and cannot be defended. Even the care home managers, in some cases, did not want to receive back these patients but were practically forced too. In my view this was a complete scandal in ineptitude and at the least manslaughter.
One of the main reactions of INFb1a is to cause cell suicide if a cell has become infected with a virus. This virus is a very effective hijacker of cells meaning replication happens fast. After about 7-10 days interferon levels are depleted in the patients who go on to be severely ill. Thus SNG believed like prior studies suggested that early treatment to boost people’s immune and protect the lungs would be most beneficial (and probably will be). Not sure they expected such a good response from later treatment (Hospitalised patients) and I certainly didn’t. I suspect that direct application to the lungs has made the difference. The sad truth is that with the virus picking up again SNG will fill the home trial quicker. Although I believe COPD data (Due in August) will also be utilised to fast track the approval process.
Don’t quite buy the second wave theory, it’s still the first bloody wave just three weeks after restrictions are lifted. Followed the same pattern in other European countries. Let’s hope powers that be get this drug out there where it’s needed otherwise we are going to lose a lot of people. It will be criminal if it could have been severely limited by the effect of this drug and this company is forced to sit on its hands. Proper second wave will be when the normal cold/flu season starts. Let’s hope it doesn’t happen but I think we all know it’s going to.
I held strong and bought some more at 193p. I can't see justification for a 10% fall in this share on no news. Fair enough if things have gone wrong but they haven't. Should SNG prove to be the drug we all hope it is then it should be at least a $billion drug. That equates to a SP of around £6.60. They ain't having my shares for £2.00.
When the hospital results came back RM was itching to try SNG001, on people who were on ventilators, literally the sickest patients. Surprised me but he was. These people would be at the severe cytokines storm stage.
The problem with the above is that phase III I believe is designed to test on larger numbers and primarily as a comparator. Currently their are only two proven drugs against Covid (excluding SNG) Remdisivir and dexamethasone. The latter has no effect in the early part of infection and may actually cause more harm as stated by Fauci, the former has no effect on mortality but has been shown to reduce length of hospital stay. So when coming to compare treatments currently their isn’t really too much competition. Hopefully this will mean the FDA et al look on us favourably when deciding expedited approvals. GLA.
To be fair to the company they have signposted the news. Phase II IBS data is due quarter 3. So end of September at the very latest but could drop any day now. Will be halfway through Q3 in a couple of weeks.
I just think this product is desperately needed and providing health authorities believe this is safe to use then it will get expedited approvals. I’m certain it will at least match if not well surpass Remdisivir in efficacy so why not?. Or put another way, knowing what you know and you go and catch COVID. What drug would you want to take. I know what my answer would be.:)
Org- people want an end to this so Vaccines are elevated to the top table but it doesn’t mean they will get one, in fact, the odds are they won’t. Their has never been a vaccine for a coronavirus. I’ll keep my fingers crossed they get one but imo they won’t. I’ve never understood why billions are being thrown at that when therapeutics will be the cheaper, quicker way to help sufferers recover. Not saying a vaccine shouldn’t be pursued but not to the cost of everything else.