I significantly reduced my position as I am sure many did to adjust for the uncertainty risk however I have always held the opinion that my capital invested here would be for a number of years and maintain some support despite a major hiccup and oversight in the trial design resulting in what we have seen over the past fortnight.
However, all is not lost.
Two possible scenarios pop into my head after the settling of the whirlwind over the past fortnight.
Both hinge on the outcome of the Independent Assessment regarding the IIH market opportunity.
1. Mid Q3 - Market Opportunity risk deemed negligible, pivoted IIH Trial to go ahead albeit with a delayed P3 readout (anticipating approx 12 month delay - pure speculation).
2. Mid Q3 - Market Opportunity risk too high and therefore pivoted IIH Trial to not go ahead.
In either scenario, we have TBI.
We will aim to obtain ODD in the US as we have successfully obtained ODD in Europe.
Scenario 1 will run, possibly alongside a proof of concept clinical trial for Exenatide to lower ICP in moderate to
severe TBI is under consideration (CR possibly required)
Scenario 2 will scrap the IIH Trial and I expect funds will be redirected to a proof of concept clinical trial for Exenatide to lower ICP in moderate to
severe TBI.
All in all, the timing of Grist exiting his position and the TBI announcement timing prior to the Phase III pause for IIH Trial left a bad taste in my mouth.
Its a shame we lost two directors but i do think there is something material here however the company is confident in continuing without them if we do proceed with a pivoted IIH Trial.
It is a long bet with significant upside if we can unlock the potential.
Lives will be changed for the better and I hope we can look back one day and call this a bad blip in a brighter story moving forward.
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