Hunt, What?
I believe we will hear of the MHRA decision the week of June 1st…most likely by Thursday June 4th…
If it goes beyond that date, then I believe we are owed an explanation as to what is behind the delay…
Investors have been very patient and trustworthy during the last 2 1/2 years since submission and if approval isn’t given by end of next week, then we should hear of the reason(s) why. Hiding behind “No announcement until decision” is reasonable for the first 18 months. However, we are beyond the point of a normal process. I assure you LP and Co. also strongly believed we would have learned of a decision within 18 months. So what gives?….I do not believe it is all MHRA delays. There is something else lurking in the dark. Regardless, it is time stakeholders are provided an update. How difficult can that be? I never expected a perfect submission and I can be understanding/forgiving, however I do expect a honest update.
As an example, if delays were caused by consultants not knowing 100% of the process for this paradigm shift and thus required us to provide additional data, etc. then any reasonable person could make an assumption that the delay would add at least 6 months+ to the approval process. Or perhaps the “assumed" extraordinary delay is due to the MHRA requiring submissions to the CHM four times vs. max of 2 for drugs. This new paradigm for GBM (and all cancer) treatments requires many new and different reviews not originally anticipated. Be assured, we have and continue to move forward meeting all the demands required. Though we don’t know the exact date when a decision will be rendered, we believe we are on a path closer to the end of the journey and looking forward to sharing such decision as soon as we hear. Please be patient with us as we near the goal line.
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