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The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst, page-647

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Quiltman

2,251 Posts.

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01/03/24

10:38

Post #: 72689486
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Originally posted by NZ Trader: ↑

IMHO we will require another Catalyst and that is FDA ODD , if you take the fact that FDA ODD is a 90 day regulated process..

The first 45 days is vetting the application and the last seems to be processing the application .. so we were 48 days in when the FDA requested further supportive information , now that PAA have the Phase I/II Data that can be provided the $200m question is "are we still now travelling through the FDA application or have we had to start again??""

if we are still travelling through the processing we have circa 45 days and BOOM we have a 7 year market exclusivity with a raft of other benefits but also a Truly Significant Catalyst .. I certainly don't have all the answers but being granted FDA ODD would place us front and centre of the current suppliers removing any doubt of the value and Threat that MPL and PAA are ...

Anyone have any Intel on the FDA Application status ?? ,, Friday Frenzy will have to wait the Wife wants Lunch in the City ... best of luck to all Holders NZT

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Here is dialogue on the subject from MT himself last night. Seems he isn't sure himself !

PAA Price at posting: 34.5¢ Sentiment: Buy Disclosure: Held
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