NorthWest Biotherapeutics Inc (NWBO)

[br8k0ut]

21st Century Cures Act was passed in 2016:

Cures Act Implications for DCVAX Direct if DCVAX-L is approved:

Additional wording in the Act allows for the approval of new indications for existing medications to be based only on “data summaries".

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5424829/


President Obama praised its final passage. “?We are now one step closer to ending cancer as we know it, unlocking cures for diseases like Alzheimer’s, and helping people seeking treatment for opioid addiction finally get the help they need,”
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Former FDA head Gottlieb on cures act:

"Known as “in silico” testing, the use of computer modeling to supplement drug and device development is a promising avenue for evaluating safety and moving new therapeutics through the approvals process.

“FDA’s Center for Drug Evaluation and Research (CDER) is currently using modeling and simulation to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety, and evaluate potential adverse event mechanisms".
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21st Century Cures Act.1 

Broadly, this $6.3 billion law provides funding for accelerating cancer research through the so-called Cancer Moonshot, increasing the understanding of the human brain through the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative, and extending precision medicine to all diseases through the Precision Medicine Initiative (PMI).
Plus, the Act allocates substantial support to the US Food and Drug Administration (FDA) in order to streamline the process for drug and medical device approvals, promote increased use of electronic health records, eliminate bureaucratic red tape, and advance the implementation of telehealth services.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5424829/