Just a few more random thoughts on Breakthrough Designation. NEU would be negligent if they did not apply first t breakthrough.
It cost us nothing to apply and only takes 60 days. Considering the fact that 2591 has done 4 X PH1 trials and 3 X PH2 trials the safety data is piled high .
Then on top of that 2591 has shown outstanding results in the PH2 trial now under discussion, it’s hard I see a reason for the FDA to hold this back from patients who desperately need help and have no other options.
We must remember the FDA also gets kudos for approving good drugs quickly and helping steer these drugs to market.
It would explain why our finalised FDA meeting notes are slow to arrive.
If we did get Breakthrough Designation the reserve price for next years auction gets moved up to $120 per share. Or AUD $15 Bn.
NEU Price at posting:
$13.32 Sentiment: None Disclosure: Held
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