Does that mean the FDA will quit being a roadblocker at that time or is that still far off?
But Perrigo didn't comment. Perrigo updated their status today, that's who I'm referring to.
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I see the update. My problem is this delay isn't seen as critical for approval by the FDA, which is ridiculous.
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I don't know how to respond to that, other than the FDA doesn't have a pathway for that, really. Blame rests on Par.
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The FDA process for modding a contract mfg takes 6-9 months, no matter what. They should have had supply to last.
End of conversation
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So dogmatic FDA processes mean little to me at the moment.
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This shortage has already greatly increased the price and reduced availability. It's downright scary.
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