IMO the wording in that presentation is deliberately equivocal and I implore shareholders to ask Mr Rogers to be a lot clearer in explaining to the market where PRR actually stands with CVAC and the US regulatory process. Whilst I'm not saying this is mis-information it certainly is far from best practice.
A phase II study should NOT be referred to as a pivotal study.
Considering how many mum and dad investors with little understanding of the US regulatory process I fear that there are going to be a lot of dissapointed people whom have been led to believe that PRR and specifically CVAC is a lot further progressed than it actually is.
The substantial funds required for a phase III pivotal trial in the US IMO will only ever be forthcoming after PRR has generated far more robust phase II data.
The capital markets or a trade partner (who will fund a phase III study) will require the phase II data as a pre-requisite and this is yet to be delivered.
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