A good idea to let things calm down a bit.This is CRL $$$ pain...

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Goldfarm

4,484 Posts.

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09/08/23

14:27

Post #: 69247423
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Originally posted by ddwn: ↑

I've taken the weekend to calm down and have not post on HC until now.
There were so many posts over this weekend and even if I was up to it, it would have been impossible for me to keep up.

Anyway, I would like to have a proper discussion without the emotions, blame game and upmanship.

I have a few lingering questions, and I hope the collective here can help:
How did the Ryoncil BLA Resubmission get a Complete Response - when the subsequent recommendation was to conduct a trial?
With CRL1 - Why would the FDA recommend Mesoblast to conduct a trial in the first place, when they had CMC issues? How were the FDA expecting Mesoblast to conduct this trial if Mesoblast didn't have a mechanism to unlock the CMC issues?
With CRL2 - Why did the FDA conduct a manufacturing inspection if they were still going to request Mesoblast to do another trial?
With the Resubmission - Why couldn't Mesoblast ask for AA, when a full approval for Ryoncil was not given? Is it too late in the process or simply a different process/ form altogether for this bureaucratic FDA? If the FDA have bent their own rules to allow #1 above to go ahead, then why are they would allow Mesoblast to ask for AA - even if it was late in the process?
If AA is a different BLA to a full approval, then why didn't Mesoblast apply for both BLA at the same time? Given that Dr Krause was leading this BLA resubmission, wouldn't he know the FDA processes?
Going forward - what is this adult study anyway? Is it to confirm the new Assays? Or is it centred around efficacy? If efficacy, how is an adult study supposed to help clarify the gaps with pediatrics?

CRL#2:

The 2020 CRL:

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A good idea to let things calm down a bit.

This is CRL $$$ pain No 2 for me. I have been involved with biotech companies for nearly 20 years and they all say FDA approval is VERY TOUGH. But I rolled the dice twice now re MSB as mentioned. The reward was great.

Sold out now at 50c. But hope to buy in at sub 30c over the next few weeks. And then third time lucky.
Last edited by Goldfarm: 09/08/23

MSB Price at posting: 35.5¢ Sentiment: None Disclosure: Not Held
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0 Great analysis

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