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Good information being posted this morning.
I'm enjoying the calm bb today. Light relief at last.
And I've had a couple "recommend".
Wait for it!
I should add SNG001 was also being used (to treat) against COPD, and was in phase II trials before that testing was paused to enable complete concentration on COVID19. Testing to that point I believe was going well so it would appear given what we know about it’s limited use against Sars, Mers, Asthma, COPD and Covid19 that this drug is a treat all respiratory lung infection drug. The upside is surely huge.
The thing is Tricky, SNG001 has been well tolerated with no major side effects as far as I’m aware. It’s been studied in over 260 Severe Asthma patients and used on other respiratory diseases showing good levels of tolerance which you would kind of expect from a protein that is naturally produced by the body. Phase III trials ,as I understand it, are to see loosely if the drug has side effects and to compare against other drugs on the market. At time of writing there isn’t any other drugs on the market that are proven. The side effects issue also looks positive on what we know so confident we can sail through phase III. 70-90% of drugs that pass into Phase III go on to market. Phase II is therefore the **** kicker! But I’m confident this drug will get through. So is the company or it wouldn’t have raised the 14m to fund its own trials and produce the interferon Beta. When you read about the company and people it employs they are perfectly positioned to lead the way against this virus.
Morning all. Popping in here as I do....been open with my position here for a while. I wish I understood this trial process better so it’s interesting to read all the comments. It just strikes me that with such an urgency needed, there must already be an indication as to whether this works. There is regrettably no shortage of potential patients from everything I read. Anyway, my interest here is as much a prayer for some form of medical win against this shocking illness as anything else. I am finding it interesting reading all the different thoughts so thank you. I guess there can only be a handful of similar situations in history where such an urgent benefit is required in a race against time and I just don’t know how that might impact protocol,.....although the need for benefits and side effects clearly has to be understood. GLA.
Agreed. This will not take 8 weeks imo.
They should be dosing the final patient by the end of next week by my estimate and that's being conservative.
It will be 20 days since the first dose was administered on Friday next week. If each of the 10 hospitals having dosed 5 patients on average each by then it will be done. They are not going to take another 4 weeks after that before deciding to move on to phase 3 imo.
What is totall unique here to any other trial is that
we have a pandemic...so that will have a huge
impact on how decisions are made...You cannot
compare any current trial looking at potential
treatments for COVID-19 to Normal trials for
Cancer and other serious conditions IMHO !
Hi John
Normally yes...but in extreme circumstances and it is rare
if the results are overwhelming and there is an urgency
they could make a decision....also there is already a
lot of data on our product....so that lessens the risk
somewhat....
It is possible but very unlikely. This is a “double blind” trial where neither the patient nor the medical person treating the patient know wether the patient is on the SNG product or placebo. The “treatment” is carried out over a two week period but it takes time to recruit all 100 patients, hence a ramp-up phase of 2 to 3 weeks. Once complete, the data will be an analysed by an independent panel. Overall, the whole process could take up to 2 months. I would expect an RNS next week to update investors on the number of hospitals & patients already on board. Fingers crossed!
I can't see them just abandoning the trial.
They may push forward and expedite the phase 3 trial but I expect the will continue with phase 2 until all data is gathered so it can be rubber stamped.
Ok, I thought they would want the data as proof.
Exactly. And John to address your point, they get zero data from placebo cases (information that is not already known anyway), so i imagine they would get more information by treating as mamy people as possible with it.
John all trials have a placebo...but if half way through
our current trial all patients on our treatment are
recovering rapidly and showing a distinct difference
to those on the placebo they could take a view
I am not saying this will happen...just that it could.GL.
GLA!
Hi MadChatter
YES that is possible...it only happens when the drug on trial shows
exceptional results and where there are extremely limited options
with altenative treatents for the illness in question. It has
happened in Cancer Trials and it definitely could happen here..
This is the perfect scenario where that decision could be made
as so many dying and as yet no treatments and a vaccine
a long way off......
The double blind placebo trial will give you the evidence you need. So no, not going to happen as we need that data.
It is possible they will abandon the trial part way through and just give everyone the treatment. Infact I'm hoping this is exactly what will happen and an rns early next week!