As long as Prana can keep doses below that level I can't see why...

As long as Prana can keep doses below that level I can't see why that should prevent PBT2 going to market. For example, look at the TNF blockers. These are some of the highest earning drugs in the market like arthritis drug Humira with earnings last year of $14B.
http://www.cnbc.com/2016/07/29/abbv...percent-on-higher-demand-for-drug-humira.html

[Tnf Blocking Agents (Includes Humira) ↔ Neurologic Reactions

Severe Potential Hazard, Moderate plausibility
Applies to: Optic Nerve Disorder, Multiple Sclerosis, Seizures, Vasculitis, Guillain-Barre Syndrome, CNS Disorder
The use of TNF blocking agents has been associated with rare cases of CNS manifestations of systemic vasculitis, seizure and new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Care should be exercised when considering the use of these agents in patients with neurologic disorders and discontinuing the agent is recommended if these disorders develop during therapy.]
https://www.drugs.com/disease-interactions/adalimumab,humira.html

Surely if Prana are not even allowed to run a trial, humira- the worlds biggest selling drug- could be re evaluated.