Anavex Life Sciences Corp (AVXL)

[nidan7500]

Nice work abew4me. Let's see where they (FDA-Politicians-WS-corruption-...)go w/this. RWD-RWE evolves into custom treatments and (GASP) an understanding that..."wait of it"...." One size does not FIT ALL....HUH". Could this mean that FDA will FINALLY redesign itself and get hard-soft science-results from RWD-RWE to redesign all of BP practices????? NAAAH....???

RWD-RWE...has to win eventually, otherwise they will not fix ...Jack Shat...again trial by BIG STATs is just wrong......confidence in a reproducible drug process is basic process control...it is simply a variation and not much more that trial and error. IMO.

Additionally, in December 2018, the FDA drafted the framework to establish a program to consider the potential of real-world evidence (RWE) as a basis for drug approval. RWE is defined by the FDA as “clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD).”

RWD is defined by the FDA as “data relating to patient health status and/or delivery of health care routinely collected from a variety of resources.” These resources include electronic medical records, medical claims data, disease and product registries, and wearable devices, among others.

Dr. Maynard suggested that “well-designed, noninterventional studies relying on fit-for-purpose RWD when compared to a suitable control can be considered adequate and well-controlled under FDA regulations.”

The FDA has also undertaken an initiative called Patient-Focused Drug Development (PFDD), in which the perspectives of patients are considered when guiding treatment development. Patients can speak of the impact that disease symptoms have on their daily lives, as well as their current management of the disease using available treatments.