IMO and experience, duration of follow-up required to demonstrate adequate safety will be in the region of 6 months. That's 6 months post enrolment and treatment of the 20th patient.
For PC, for 20 patients, a 6 month enrolment phase is agressive. That's a combined minimum of 12 months until pilot safety data is available via the IDE study. After/if it actually gets a site on board.
Should the resulting IDE safety data be good enough to support a subsequent pivotal IDE application / subsequent comparative randomised pivotal study (chemo plus oncosil versus oncosil alone), and, should the resulting pivotal study data demonstrate that oncosil significantly increases time to local PC progression (per previous ANNS and recent Wilson report endpoints), then CE approval is possible.
180+ patient enrolment plus follow up = at least 2-3 years.
It is inconceivable that CE approval will be granted based on the results of a non-comparator safety study with a sample size of 20.
So CE approval is not only an impossibility in 2016, but also in 2017, 2018, and 2019. Perhaps in 2020, results dependent.
Of course none of this really matters to those who have something to gain by continuing to pull the wool over the eyes of shareholders.
By that time the failure will be attributable to lack of product performance, or lack of funds to proceed.
Sadly, with continued shareholder support (funding), Mr. Kenny can only win. An on-going salary, super, and duration of tenure related bonuses, might just be motivation enough to justify repeated declaration of unrealistic and unachievable "expectations".
What has been promised to in the past 2 years?
CE approval, TGA approval, commercial sales in Europe, Australia, New Zealand, Canada, Singapore. Clinicial trials in Australia and the U.S.A.
What has been delivered in the past 2 years?
IDE approval for a 20 patient pilot safety study, as yet to have a participating site approved.
Believe what you will but the evidence is clear and the track record murky.
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