Re: Last day of June.
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Jul 02, 2021 04:05PM
Thanks! Within 30 days.
So we're either dosing, or still waiting!
Just checked back on Imtesty's AGM notes from June 22nd.
If we're not dosing yet, maybe we're still tied up with this? If these committees don't meet every week, we're at their mercy!
We have pending ethics approval reviews at various hospitals in Ontario, Alberta and Quebec. And the first full submission will be later this week.
On Slide Eight, I’d like to give you an update of where we are on the clinical trial launch. I think this is what a lot of people are most interested in right now. Remember, like I said, we’ve only had approval for this program for two months. Clinical trials listed the trial start as June 12th. But internally, a trial starts once you start spending money. And that was in April, sixty days ago. So rapid response has been made in these two short months. We’ve signed a very experienced CRO to handle this trial for us. They already experience with twenty COVID trials under their belt. So they bring a lot of knowledge and expertise to the table with us. We’ve designed a proper and affordable program. We’ve revised it a little bit, cutting back some expenses on what are now deemed out there as unnecessary lab work and probably saved an extra half a million dollars doing that. So it slows you down maybe a week or two here and there, but our job is to get it right. And get it as affordable program as possible. We’ve also arranged a back-up plan in Brazil. As we all know, we’re all experts on COVID now, whether we like it or not. We all know that these bubbles shift and change around a lot. So if you’re just working in Canada and you run through a slow-down it could be six months before you have a proper patient base. I believe our results will encourage a lot of people to want to be in this trial, so... We can’t guarantee time frames; we can’t tell you when things are going to happen in advance because they are not in our control. We certainly can tell you when they happen, and that’s what we will be doing. But we do have Brazil all set up now as a backup. Well, it’s not just a backup, it will be going in parallel so as the waves of patients shift around, we feel we’re well covered.
We’ve also in this short period of time confirmed principal investigators. We have pending ethics approval reviews at various hospitals in Ontario, Alberta and Quebec. And the first full submission will be later this week. We were able to re-label the drug and transfer it from Europe, moving it around. So there’s a lot of activity that was taking place behind the scenes. You don’t just say hey we’re in a trial let’s dose somebody tomorrow. It doesn’t work that way.
All this has been done during a massive pandemic, with considerable competition. At year’s end last year I was telling you that there were 3,200 COVID related trials ongoing. There are currently now 5,900. And yes the yoghurt one is still in there. So there’s a lot of distraction a lot of stress on an already extremely stressed medical system. The doctors and staff are burnt out, many taking leave to recover. I’ve seen it personally. And after putting all of their life-saving efforts and incredible work that they do, watching politicians and non-vaxxers treat the reality as a joke and it’s very harmful for our medical staff and their well-being. So we need to rethink this in the future.
Our dual mechanism approach is bringing great hope and expectation to these people, so we expect this to be a very positive result. And really the dual mechanism of – in the first place trying to stop COVID from even getting in to the cells through the ACE-2 receptors and the PPH4 – that’s a very good opportunity for us, but being able to stop the cytokine storms and turn back the clock on that is exactly what was highlighted in the Cell publication from the Australian group. It’s a phenomenal publication, very helpful, and they were showing the reversal of the damage. So it’s not just about COVID. It’s about the damage and the cardiovascular, pulmonary and kidney, and trying to correct some of that going forward. It’s the unique approach we have in the dual mechanism.