Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-953

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col69

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14/06/24

15:56

Post #: 74320440
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Originally posted by JB1975 ↑

What do you think led FDA to tell us we can refile?

Frankly, I don't believe they did.

Even though, and I've just rechecked the statement made by reporter Cameron England again at 3.53PM June 10, 2024 in The Australian - headlined "US Food and Drug Administration acceptance of Mesoblast data bodes well for growth" says -

Quote (yellowing is mine) "
Mesoblast was asked for additional data, and went back to the FDA inJanuary, expecting to be told what more needed to be done on thestudy front.
“And instead,what they said was ‘no, we’ve thought this through, and you’veconvinced us that the clinical data are very strong’,’’ ProfItescu said.

“You’ve gotenough to get approved for children – go ahead and file, and thenconsider how to take the product into adults.’’
" unquote.

I still cannot believe it is true. I would need corroborating evidence to believe it (some sort of description of what data had changed, some sort of reference to who was actually at the meeting - was Matt Klinker sick, tied up, replaced?) and I don't think that is going to be forthcoming.

I don't believe the FDA would talk like that.

That underlined bit is still in quotes and it reads like Silviu is saying someone at the FDA said "and then consider how to take the product into adults" like the FDA was giving out business advice suddenly in pithy little quotes.

Like some sort of adolescent dreaming of the perfect statement to come from the person they most wanted to hear say exactly that but it doesn't sound like what a professional would say to me.

And the FDA official isn't named. So there is deniability everywhere. Silviu could say he was misquoted (if shareholders later said they relied on his statements). And it (deniability) will remain there unless steps are taken to remove it.

This would be a huge case of the FDA moving the goal posts MSBs way. It would be like the mountain deciding well shucks poor mohomad over there sitting by himself, I think I'll got and see if wants some some company and offer some travel tips to mecca into the bargain.

Clearly something is different - only if you trust the deniable narrative. The FDA hasn't spoken for themselves. The patent office hasn't approved the patent application that contains the IL@ralpha part of the potency assay.

I am not trusting it.

Expand

What do you think led FDA to tell us we can refile?

Frankly, I don't believe they did.

Now that’s gold @JB1975 … so Mesoblast are just refiling the BLA submission for fun without the FDAs permission ? …. you can’t make this stuff up …. and people wonder why I claim you cannot take this guy seriously …. enough said lol

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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-953

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