Ann: Novartis and Mesoblast Remestemcel-L Collaboration, page-300

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20/11/20

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Post #: 49027970
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Originally posted by Bazsa: ↑

I generally do my best not to reply to you however if you remain respectful I will try to answer to the best of my ability.
With any of these partnerships it is a balance between short term $$$ and the long term. Very similar to the FF deal that you guys made way back. The difference hear however is that both parties will be highly motivated to push forward in every direction. In contrast your management failed to work with FF instead they insulted FF by a public statement ( Christmas Card ).

Re manufacturing: I agree, it looks like we are onto a winner , and we will need to put those blue prints into production if the ARDS results are as we hope . Time line is important only in the short term in regards to COVID ARDS . It's my understanding that they have been busy creating a master cell bank. I don't think the 3D part of the manufacturing process is particularly difficult , it will be more about environment control standards.
Validation of the process could take a while , depends on the FDA and there requirements at the time of asking the question. Under Emergency Use 6 months , for full approval under the current FDA structure and new Administration , 1 to 2 years most likely including constantly monitoring to insure batch to batch efficacy.

Now onto the topic of the FDA and it apararant refusal to grant accelerated approval. This is nothing more than a waiting game for results of the COVID trial. We do however need to wait for the minutes of the meeting that will have their decision after that we go to a public meeting. Feb March next year , we can also ask for a ODAC panel . While I think this meeting is unlikely to be needed it will make for some compelling late night viewing.

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"The difference hear however is that both parties will be highly motivated to push forward in every direction. In contrast your management failed to work with FF instead they insulted FF by a public statement ( Christmas Card )."

OMG - I am truly wasting my time readin your garbage.

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