(Total Views: 638)
Posted On: 09/22/2020 10:27:33 PM
Post# of 155577
Thoughts on the interview
- Psyched that we get to learn about NASDAQ uplisting in the next two days
- Great to see us get some published peer review papers/accepted talks getting out there...VALIDATION!
- Long Haulers protocol nearing completion and expecting it to enroll quickly
- Sounds like we will need to work with the CRO to determine if it makes sense to take the penalty hit on the p value for our CD12 interim results in order to release them. Curious what the stats folks think about that?
- They seem a little more resigned to having to complete phase 3 trials in COVID than I have heard them on previous calls, at least with the FDA (I think his comment that if you need approval in 2 months vs 6 months you should sell emphasized this)
- I asked if they had any concerns about other therapeutics getting approval in the short term affecting our ability to enroll. They seemed to suggest it wouldn't have an impact. I am not sure if I agree but I think their contention is that they slow rolled enrollment intentionally to focus on other things. Curious how long it will take to get these 5 (with potential for 10) sites up and running in the UK.
- They confirmed that they are doing EAMS and are applying for PIM as I posted earlier. I am not sure how this works given that they are submitting EIND data (that wasn't in the flow chart
Perhaps if they can get MHRA interim data from a phase 3 trial (195 patients) that suffices for PIM since it is based on Phase 1 or Phase 2 data typically?
Interesting new bits of information. Hoping NASDAQ is a go!!!
- Psyched that we get to learn about NASDAQ uplisting in the next two days
- Great to see us get some published peer review papers/accepted talks getting out there...VALIDATION!
- Long Haulers protocol nearing completion and expecting it to enroll quickly
- Sounds like we will need to work with the CRO to determine if it makes sense to take the penalty hit on the p value for our CD12 interim results in order to release them. Curious what the stats folks think about that?
- They seem a little more resigned to having to complete phase 3 trials in COVID than I have heard them on previous calls, at least with the FDA (I think his comment that if you need approval in 2 months vs 6 months you should sell emphasized this)
- I asked if they had any concerns about other therapeutics getting approval in the short term affecting our ability to enroll. They seemed to suggest it wouldn't have an impact. I am not sure if I agree but I think their contention is that they slow rolled enrollment intentionally to focus on other things. Curious how long it will take to get these 5 (with potential for 10) sites up and running in the UK.
- They confirmed that they are doing EAMS and are applying for PIM as I posted earlier. I am not sure how this works given that they are submitting EIND data (that wasn't in the flow chart
Perhaps if they can get MHRA interim data from a phase 3 trial (195 patients) that suffices for PIM since it is based on Phase 1 or Phase 2 data typically? Interesting new bits of information. Hoping NASDAQ is a go!!!
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