Have people considered that delay may not be anything to do with...

Have people considered that delay may not be anything to do with MSBs data or Novartis. US government also has input by the 30 day review period.

So why would the US government perhaps be involved?
Remectemcell is very much on the radar at the highest level, make no mistake and the technology could well come in as " restricted access "

Thanks to @Sector I have been doing a little research and diving into the history. Yes this article dates back a long time.

A US contract for the supply of 20 000 doses worth nearly a quarter of a billion dollars with Osiris for the treatment of radiation exposure. Remember this is history or is it. 10 years + 3

https://ryortho.com/2011/08/five-stem-cell-companies-in-orthopedics/

Osiris Therapeutics, Inc. — The U.S. Government is about to be the largest purchaser of stem cell products in the world. Three years ago the Department of Defense gave a $224.7 million contract to Osiris for its adult mesenchymal stem cell (MSC) therapy as a medical countermeasure to nuclear terrorism and other radiological emergencies.

Mesoblast technology !!