Unfortunately, we don't know precisely what the FDA said! For a...

Unfortunately, we don't know precisely what the FDA said! For a properly informed market, we need disclosure of the key issues in each of the CRL's. At the moment we only have a few carefully curated snippets of information.

As an example, we are told that the FDA "acknowledged improvements to our potency assay" - that unfortunately does not mean that they actually approved it. So that may still be a CRL issue. Similarly, still on CMC, we are told "FDA’s inspection of our manufacturing process resulted in no observed concerns" - the inspection only covers GMP compliance and conformance to the submitted CMC data, it does not mean the FDA accepts that the process is robust and reproducible (the GMP inspectors do not have the expertise to form that judgement). So again, that does not exclude the possibility that manufacturing is still an issue on the CRL.

If MSB is truly keen to restore trust in the investment community (and I don't just mean the folks here on HotCopper, I mean the big institutional investors MSB are going to need soon to support a significant capital raise), it needs to at least provide a summary of all the key points in each of the CRL's - that is the only way investors can assess whether any real progress has been made, and what the remaining hurdles ahead are.

At the moment, the market is uninformed.