Hopefully, but I would rather them take their time than rush it through in this current environment and get a bad deal. I believe with more evidence we can de risk 2RT a bit more and therefore get a better valuation. This will take another year at least. Keep in mind the LEAD trial was a failure, and some prominent individuals in the ophthalmology industry have come out criticising the sub analysis (though, these individuals as I have mentioned before have financial interests in competitors). Therefore, I believe that the results of the LIANA trial are definitely necessary before a partnership can be made (if we want a good deal).
iTrack advance is another issue, depending on the feedback we could be looking at another six months or more if they are struggling to meet the substantially equivalent criteria (which was somewhat alluded to in the announcement when it talked about the uniqueness of iTrack). There are alternative pathways to get clearance so I am almost 100% confident that itrack will be cleared, but that may potentially come much later than we hope. The FDA are notoriously slow and there is typically a 2 month plus wait time to even secure a meeting to deal with the “extra information” request.
Assuming the CATALYST trial is the missing piece that the FDA want to prove iTrack is SE to predicate devices, we could be looking at several months to receive the results of that trial plus a 1-2 month wait time to meet with the FDA to present this information. After that the FDA could take approx a month to analyse the new info plus the old before making their decision on whether or not the device is SE.
I do wish the company would come out with the feedback received from the FDA to save us from speculating. I can only presume that they are not disclosing it because it isn’t pretty… as a holder with hundreds of thousands of shares I would appreciate a bit more info to calm my nerves
Lets hope the half year report in February will clear things up a bit
Hopefully, but I would rather them take their time than rush it...
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