2023 The Final Countdown, page-1991

@whytee If I keep repeating this - it is because it is true: You are purporsefully making false, deceptive arguments.

This is getting tedious.

"If that was even remotely true, then the FDA wouldn't have wasted time and money convening an ODA meeting during the original BLA, since they ended up issuing a CRL anyway."

You are discounting the fact that the CRL was the accumulation of the FDAs assessment, at the time, inclusive of ODAC. You are ignoring the FDAs own SOPs that states that a resubmission wont be accepted if they felt there were deficiencies in their application. You are playing ignorant to facts that at least suggest a plausible alternative.

I would agree if you said that it is possible that acceptance of the resubmission may still be subject to a propper assessment of the data provided, and the fda may still feel that it is not enough - but to outright pretend there is definitively nothing there is deceptive.

"Very recently the FDA rejected an application for a major drug company to extend the labelling by increasing the doseage of an existing popular drug based on the failed inspection of a third party manufacturing facility."

You are doing THIS AGAIN.

• What Company Whytee?
• What Drug?
• What Indication?
• Why are you being so vague?

• Are you employed by, or providing services to, that company or an affiliate?

• Finish your dang arguments properly!

Are you being vague because it wasnt actually based on a third part manufacturing facility but because the drug is so toxic and has a poor safety profile? Did you lie regarding the manufacturing all together? "they still issued a CRL AFTER all the evidence had been submitted". Is that because the evidence showed that the drug is unlikely to be more effective at the higher dosage?

I am only guessing which drug you are talking about because you have not provided any details.

And if it is what I think it is then their situation has absolutely nothing to do with the current submission and you are being deceptive in trying to relate it to Mesoblast.

Heck - I could be wrong.

You just havent finished your arguments.