Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-1067

Meanwhile over at see why pee, JB saying Klinker must not be across the latest developments and suggesting that the 20 year NewsCorp business editor is possibly a rookie.

https://fda.zoomgov.com/rec/play/sio00ZZ27mnDZabNW6wrm2GjRDAlIu7RGhYnhKGjatcMVlwdjhN7_aipv4j8XG-HspUww2HSSjS2gyZI.4bmk95suGraJdV7z

This is an excerpt from the FDA's latest end of 2023 guidance for potency assays in cellular products- definitely watch the video- getting our manufacturing process assessed and approved appears to have assisted in getting us over the FDA stumbling block re 001 potency assay issues. As a lay person it seems they have proven scientifically why Prochymal did not work but also why Ryoncil did work. The IL2r alpha assay has demonstrated that the 001 trial product matches the current product.
If the FDA is not questioning efficacy and the product is the same ,then for an unmet need, it appears there has been flexibility from the FDA's side. Prior guidance from 2011 had zero flexibility.

• 

  Matthew Klinker

  09:58
  While this new approach I've just described is certainly broader. It is also more flexible. If there are limitations in one aspect of your potency, assurance, strategy, other aspects of the strategy may be able to compensate for those limitations
• for some products. The potency-related Tqas might not be well understood, or might be difficult to measure reliably. And as a result, lot-release testing may not be able to fully confirm product potency.
• But other aspects of the potency, assurance, strategy, such as process, design, and control to take on increased importance in these cases, and be made more stringent and extensive. The
• this adaptability is one of the key strengths of this broader approach the
• and it provides other tools beyond potency test for controlling product potency.

• 
  
  Reg - broke the 4th Commandment