Thought it would be useful to start a discussion regarding the anticipated IRB approvals for the follow up US pediatric study.Cleveland – 10 Oct (e.g. tomorrow our time we could see an announcement)
With reference to last year’s timeline, I would assume these approvals should be forthcoming very soon. This is because last year we received the first IRB Approval on 21 Oct, the final IRB approval on 16 Nov, and the study commenced 9 Dec 2016. Therefore, for the follow up study to commence prior to the onset of the US winter (as management have reiterated on numerous occasions), we should expect this year’s approvals to follow a similar time frame. For this reason, I am confident we will see at least one of these approvals (hopefully more) this month.
I did a bit of research into the IRB meeting dates at the relevant US hospitals involved in the study. Below are the relevant links that I found.
Mass - https://www.umassmed.edu/ccts/irb/meetings/
Cleveland - http://www.uhhospitals.org/clinical-research/institutional-review-board
Texas - https://www.utmb.edu/research/home/irb/meetings
I did have a bit of trouble locating them, so pls correct me if I have stumped across the wrong ones.
However, going off the above information, the next approval dates for the respective hospitals are:
Texas – 13 Oct
Mass – 17 Oct
Although the approvals may not be forthcoming by the above dates, as the study protocols have now been finalised, it would be reasonable to assume they will be either granted on these dates or at the following meeting. Whilst announcements regarding the IRB approvals may not drive the price up in the short term, I think from a long term holder perspective it would give me, (and I assume others), great confidence that management really mean business and are driver to keep to the schedule time frame. I think these approvals will also pair well with the presentations announced and will assist management to demonstrate that the US trial is all systems go and that potential investors should jump up board now.Would be interested to hear other people's thoughts. Cheers
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Anticipated IRB approvals
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