Tuesday, January 15, 2019 2:18:35 PM
"Although an estimate of the timing and costs for the development milestones in Q4 of 2018 and beyond remains
highly speculative, the Company presently estimates that a total of US $55 million of additional capital, inclusive of
amounts raised through the Offering, will be required to fund development work through submission of the 510(k)
application to The Food and Drug Administration of the United States Department of Health and Human Services
(the “FDA”) and submittal to European authorities for the CE Mark, which are projected by year-end 2018.
However, given the uncertainty of, among other things, product development timelines, regulatory requirements, the
timing and number of future animal studies, human cadaver and clinical studies that may be required, and the
availability of required capital to fund development and operating costs, the actual costs and development times may
exceed management’s current expectations."
That doesn't sound to me like a firm promise to file in Q4 2018. It sounds like a plan to try to achieve, pending what turned out to be subsequent clarifications from the FDA regarding the timing and number of clinical studies, etc. Did he lie, or did several people on a message board cherry-pick bits of info from a formal, legal document which clearly stated the inherent schedule risks as known at that time? I'd say the latter. I wish you were right and he was a liar, because that would so much more convenient and easy to point a finger at.
No need to re-post this every day; I still think that would be a waste of everyone's time. And I'll gladly compensate for my memory issues by retrieving FACTS as needed, thank you.
There may be no need to thank you, but I'll do it anyway, as I recognize the time and effort you do put into this exercise on a daily basis.
BigT, could you please pass me the Grey Poupon? My caviar is a tad dry today and isn't sitting well with the Lagavulin.
Message in reply to:
Everyone here remembers him saying that....except you apparently....
My memory of his quote may actually be spot on but because you asked for it I will find it and post it EVERYDAY.
Not a waste of time since you obviously have memory issues. This way you’ll have a hard time forgetting it. No need to thank me
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