Tuesday, November 01, 2022 3:54:02 PM
Dear Natalie,
I hope you are in a much better condition than Tetra. I wonder what you think you can tell me:
Initially, your CEO was expecting the Reduvo approval for latest end of 2021. I checked in the meantime the performance of Health Canada and found that in the worst case, the approval process for a drug took 24 months. We will reach the worst case, 24 months, in December 2022. Does your company know that we will even be the new record and take longer than 24 months?
The intermediate results for Reborn - FDA trial- were planned for June 22. You modified the trial twice to be faster than initially seen. We are now 16 months into the trials without any report for results. The performance of Reborn can be seen daily, but no indications are given about enrollment (done or not?) and performance (within expectations or not).
We are approaching the last resistance before we fall over the cliff down to 0.006. Does the CEO want us to fall over the cliff? I trust, Reborn is working, but maybe you can't manage the enrollment. Perhaps something went very wrong?
Maybe the CEO feel burnt after all his promises last year in June failed so dramatically. Even if he doesn't want anymore give predictions some info could keep us alive such following messages:
We still wait for the approval. So far no negative indications that it will not take place.
The Reborn trial is smoothly running; enrollment is very slow, but we have managed so far xy %. After complete enrollment, it will take us another xy months for results.
I think your CEO should consider that people like me and many others invested in Tetra based on excellent preliminary results. We need to come back to a climate of hope and trust.
Could you please let your CEO know?
kindest regards
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