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24.5¢ paradigm biopharmaceuticals limited..

I agree...Remember, we got a Fast Track based on what?Read the...

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Mozzarc

4,093 Posts.

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22/03/24

10:26

Post #: 73008859
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Originally posted by Denial: ↑

You seem to see FDA cautionary approach as black and white. They naturally wanted to test min effective dosage given its potential wide scale application across the broader US population BUT also with a pre agreed threshold (benchmark) that was based on 2x2 efficacy.

NOEL will NOT be an issue with 2x2 given previous and new studies undertaken. Nevertheless we have to supply all the necessary data for them to green light stage 2 at 2x2.
Whilst it has added significant cost and now time using a two staged approach to P3, it has also ensured we have a very high chance of passing the key end points given the known efficacy of 2x2.

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I agree...

Remember, we got a Fast Track based on what?

Read the above, we got a FT based on that submission³. That's littered with evidence of the 2 x 2 or even greater...Our Phase 2B 005, even EAP (USA!) and GHOSH and KUMAGAI studies

GHOSH's study was 3mg/kg !

Kumagai?

EAP Program (In USA)

All of these program's data was submitted as the basis for FT acceptance, the dosings were all 2mg/kg or greater.

REFRENCES

1) https://pubmed.ncbi.nlm.nih.gov/24678076/
2) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2873929/
3) https://app.sharelinktechnologies.com/announcement/asx/d3ce3910e046ad93af80e361326f9d48
4) https://app.sharelinktechnologies.com/announcement/asx/53eb6ac3e5970e6fdf32dccc78411a3d

Last edited by Mozzarc: 22/03/24

PAR Price at posting: 36.0¢ Sentiment: Buy Disclosure: Held
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3 Great analysis

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