So you don’t know. And you’re trying to justify they didn’t dose...

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Gan_Gans

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11/10/23

20:01

Post #: 70295804
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Originally posted by Denial: ↑

I'm not sure what you mean by 'clinical hold'. I assume you mean we're not approved to use 2mg/kg x 2 for Stage 1?

As you know the FDA requested we try lowest dosage (min effective dose) in Stage 1 over safety concerns over the adrenal gland in 1 rat in a historical study. This rat study has subsequently been retested by PAR to confirm the SAE hasn't anything to do with PPS.

Stage 2 gives PAR the opportunity to move back to known optimal dosage 2mg/kg X 2 based on (1) safety (2) interim results for first 300 patients. Whether all relevant iPPS dosages or just the 1.5mg/kg X 2 get updated is what the FDA will determine when finalising dosage for 002 and 003.

During Stage 1 agreed dosage:

1.5mg/kg of body weight 2X weekly
2mg/kg of body weight 1X weekly + placebo 1X weekly
Fixed doses including 100mg (≤65 kg), 150mg (>65 to ≤90 kg) or 180mg (>90 kg) + placebo 1X weekly

My understanding is that the FDA are not going to mandate we must continue to use 1.5mg/kg x 2 for OA002 given the stage gate approach has allowed us to confirm lowest effective dose is not any of the above.

PAR has previously reported OA008 to the FDA that participants receiving 2mg/kg 2X weekly demonstrated a statistically significant improvement at Day 56 in pain, function, stiffness, and overall WOMAC scores compared to the placebo arm. These are the same primary end points for 002 and 003. Given OA008 achieved this finding with flying colours and repeated via SAS, NFL, 2B using dosage of 2mg/kg x 2 it would seem once FDA confirms this dosage for 002 and 003 we're on our way to an NDA.

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So you don’t know. And you’re trying to justify they didn’t dose what they knew to be efficacious due to “exploring the lowest safest dose.”

Thanks.
PAR Price at posting: 60.5¢ Sentiment: Hold Disclosure: Held
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