I'm seriously trying to understand the yellow-brick-road logic that leads some people to keep "banging on" about manufacturing. It seems to be encapsulated in this quote which is loaded with misconceptions... from the same person who told us a contract cannot be enforced unless it goes to a multi-million dollar closing. There seems to be a (mistaken) premise that clinical trials conducted using "2-D" cells will become invalid if manufacturing shifts to 3-D to allow scale up. Suggesting we can actually label cells 2-D or 3-D as if there's some significant difference between the two.
I would encourage anyone with concerns in this area to review FDA QdB and QTPP Guidelines. The issue over cells manufactured by Osiris over 10 years ago related to subsequent identification of certain biomarkers that correlate with efficacy. SI gave a detailed explanation during his ODAC testimony on critical quality attributes. Batch to batch consistency (and therefore efficacy) can be assured by monitoring these biomarkers, one in particular.
Now read again the statement made by the company in February about the Type A meeting with the FDA in November after ODAC and after the CRL: "However, there was consensus with the (FDA) review team on the proposed optimization of potency assays and on the use of biomarkers to demonstrate the the product's bioactivity in vivo." BINGO. That statement is huge. Why?? Because it means the concerns about CQA's and batch-to-batch consistency raised by the FDA at the ODAC hearings have been addressed.
The FDA does not require fully scaled-up factories to be built in order to conduct clinical trials. That's encompassed in the move to QbD and QTPP guidelines. Stop thinking about 2-D cells vs. 3-D cells. As long as the biomarkers and potency assays align they are remestemcel-L cells. That's why the February announcement by the company is so important, really a breakthrough with the FDA for all cell-based therapies. Time to stop banging on about ODAC and management incompetence when your criticisms are based on your own obvious misunderstandings. Comparable to the misunderstanding of contract law. Rather than recognizing that you're in over your head on the technical aspects of this investment, you keep bouncing back up. Reminds me of the Palooka Joe punching bag I had as a kid. He withstood many punches but finally succumbed to a small pin-prick that depleted his one Critical Quality Attribute, hot air. glta
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