Sorry if this has been addressed, I had a question on the upcoming trial results of MSB in correlation to concerns expressed about manufacturing during ODAC hearing.
If FDA has concerns about quality of batches, and the complex nature of manufacturing, will they approve any other successful trial results...even if label extension....(Covid-19 ards trials.... or CLPB or CHF....assuming they are all successful ) for manufacturing till they see the results from perdiatric aGVHD?? Arent they more likely to stand up and say ...."Lets see how these issues area addressed aGVHD scaled delivery and then we can consider approving COVID-19 label extension" (assuming ARDS trials intermediate results show overwhelming efficacy)?
Earlier I assumed that Temcel's existence for last 2 years is a good enough data for anyone to even question these things...but the fact that it is even brought up, time & again...proves it wont go away till enough has flown under the bridge.
Sorry if this has been addressed, I had a question on the...
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