Clinical Hold Complete Response Might recall that on the 29th of November 2019 we were told:
‘Theralase is currently addressing these deficiencies and expects to provide the FDA with a Clinical Hold Complete Response prior to December 31, 2019 for review by the FDA.’
It was not until the 7th of January 2020 that we were then told that the Clinical Hold Complete Response might not in fact be submitted until as late as the 31st of March 2020.
Had they initially misunderstood the nature of the required response? Did the answer to the question get more and more difficult each time they read it?
Highly improbable - that`s not the way our geniuses do Science.
Looks much more like they had a re-think and decided that the timing of the Clinical Hold Complete Response would be tactical and it may prove that they do not wish to publish anything at all positive - and particularly an IND approval - before the 3rd of March.
When might they put the Complete Response in? The FDA must respond to one within 30 days` but could do so much sooner.To be safe they may decide not to submit until late Feb and for the same reason we might not hear any other positive news before the 3rd of March either.