NEU 2.67% $1.10 neuren pharmaceuticals limited

FDA Grants Orphan Drug Designation

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    Overnight my US investor contacts informed me that the FDA has granted orphan drug designation to Neuron for its Rett Syndrome drug. This is great news as it is just the 1st part in the FDA decision making process with a decision on breakthrough designation to come next. We should get confirmation from NEU on Monday of this and this is very bullish and should see the uptrend continue. This granting of orphan drug status will give Neuron and additional 7 years exclusivity on the drug in turn basically extending the patent life an additional 7 years. Importantly this now allows the FDA to priority review Neuron's drug for Rett syndrome which is very bullish for receiving breakthrough designation. Orphan drug designation bodes very well for the next step in breakthrough designation which will be very very bullish for NEU when that hurdle is next jumped.

    Recently the FDA has been inundated with lobbying pressure from patient groups for the approval of brain drugs with these groups not wanting to wait for the full approval process. For this reason breakthrough designation has now become a key in the next boom of breakthrough designation brain drugs. Also recently on the 27th of jan the US congress met to pass the Cure Act that further strengthens the FDA's ability to approve neuroscience and CNS (Central Nervous System) treatments after extensive pressure from patient groups.

    It is not just patient lobbying but advancements in genetics and clinical science that will lead to a flood of new treatments for Autism, Depression, Alzheimer's and even Schizophrenia. Neuron is the leader in this field on the ASX and i would expect NEU to 1 day be the next billion $ ASX bio. The last pop into the teens was the last sale i will do now for NEU and wait for further developments now as we surge towards breakthrough designation and a move towards i believe a 500 mill market cap. I have also got in on the ground floor in Actinogen (ACW) as the brain drugs boom is very much on the way and with a market cap there of only 31 mill the upside is huge in just their Alzheimer's Dementia drug. Brain diseases are a major burden on sufferers and society as a whole and i believe 2 ASX companies will set the world alight as they develop their drugs to fight these diseases. Bring on Monday.
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