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Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-1005

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LearningEachDay

5,590 Posts.

2029

13/07/23

03:48

Post #: 68758890
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Originally posted by whytee: ↑

Lets look at your statements from a rational perspective

"The FDA are in charge of approvals, not random petitions"

1. Yes the FDA are in charge of the approvals, and the petition doesn't change that. Actually by petitioning the FDA over the BLA application they are actually acknowledging that authority.

2. The petition isn't random. It's a petition from a commercial competitor that reminds the FDA of previous statements they made in relation to the original Remestemcel BLA

"They have their own processes , checks and balances that need to be followed... They will review the BLA in accordance with regulatory practices"
Yes agreed. The FDA should and likely will follow their normal regulatory evaluation process without fear or favour.

" If there are any valid points in the petition, they would have already been looked at by the FDA as part of the review, and approval will answer any questions the petition may have created."

That being the case then there would be no reason to be upset about the petitiion, it simply goes over previous points made by the FDA during the last BLA. If any of the points are valid they will be taken into consideration. An entirely reasonable statement although I'm not to sure about the "already" bit. The review is likely still current.

"As you can see the petition is literally full of confounded questions that make no sense whatsoever, and baseless accusations made by someone who is not privileged to even know what has been done as part of BLA"

Now here's where you really go off the rails with "full of confounded questions that make no sense" and "baseles accusations". You don't really want to leave it up the the FDA, just to make sure you take the shot gun out and trigger both barrels. You actually want to offer a completely negative and extreme opinion about the content of the petition...

But it doesn't matter a bit. You're playing to your own audience on HC and the FDA will make its own decision.

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" The review is likely still current."

No. 3 weeks away, the review is complete. The decision is made. What is left is either documenting the reasons for the denial, or finalizing the label and preparing the press release.

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Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-1005

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Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-1005

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