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They're arguing about labeling and post market surveillance; not efficacy.

Thanks Fuma. I guess my worry is that I think labeling can hugely impact how big the market is for the drug. But we don’t know what the FDA’s beef with labeling/postmarketing is and I trust the Experienced CEO.

Regarding my own shares I’m inclined to let them ride. I once owned shares of a drug company who had their PDUFA date postponed by 3 months after the FDA said they needed the extra time due to the drug company supplying additional information regarding the proposed drug’s manufacturing facility.

The unexpected delay produced a +20% overnight drop but shares recovered within weeks.

We’ll see, good luck,
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