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sokol:And why not file only one, but make

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nidan7500   Monday, 07/08/19 12:25:03 PM
Re: sokol post# 200012
Post # of 232482 
sokol:
Quote:
And why not file only one, but make it large enough for the future - next 3 years. A shelf offering is good for 3 years



IMO, all of this is about time. We are compressing events over time by having the shelf processed now before any backlog of what's next questions develop. We have multiple/repetitive trials running in separate countries, concurrently. This strategy will accelerate the #events/compress action to accomplish more in as short a period as possible w/o compromising results or process credibility.

We should also be aware that by having multiple trials running with different country regulatory agencies we increase the power/strength and validity of the treatment data. Multiple systems in different environments each independent of each other when providing identical or very similar results makes a strong statement about treatment robustness and efficacy validation.

We have asked the question on why 3 countries, why multiple trials simultaneously, WHY, WHY, WHY...? The answer is to save time and b/c the stuff works. AND, A lot of very sick people are depending on us.

BTW, this is NOT the kind of thing one does w/a weak product.For obvious reasons.

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