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Re: Investor2014 post# 274824

Friday, 10/09/2020 12:49:18 PM

Friday, October 09, 2020 12:49:18 PM

Post# of 462256

Likelihood of ERT's software being used for the PDD trial seems quite high.



It's good to know that this kind of capability is in use. Where and when and how much will certainly surface as appropriate. Lots of dots to connect , the sooner the better. I am confident that our PDD trial result is not delayed b/c it failed. My current thinking is the PDD trial results are massively complicated and spread over several countries and data sources, all of which are CRO service constrained.

Additionally, I wonder what happens in trials where subjects (PDD) are just "Flatlined" how are results computed when (as far as we know) previously no one has ever walked away from PDD diagnosis, they only digress/pass away. I am familiar with a failure curve used to track semiconductor device failures (bathtub Curve). We would of course see any failures, but what if we have no additional failures, only flatliners?? No changes seen or only very minor improvements. Is that a win? Have not studied the criteria that closely to see if stable is set equal to pass. The timelines need clarifications IMO. The assumption I think in these trial models is, if no failure in a subject of known disease, then pass. IMO, we will probably not see an upslope (regen) in PDD subjects but am guessing. Does not failure = pass?, Where failure= degradation of condition (gets worse).

Bathtub curves are common of course where we have initial/infant mortality, followed by useful life (flatline) period then a period of failures (long life then death). What if the flatline period is decades long? is that a trial win?

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