I think any tough questions have already been answered leading up to the application.....
Recall this announcement at the start of the year:
On that basis 30-90days should be a formality .... the home stretch always seems an eternity
- Melbourne, Australia; 28 January 2016: Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), has received favourable advice from the UK Medicines and Healthcare products Regulatory Agency (MHRA), following a successful scientific advice meeting, which took place earlier this month.
The MHRA confirmed that Cynata’s proprietary CymerusTM mesenchymal stem cell (MSC) product, CYP-001, is considered to be suitable for use in a proposed Phase 1 clinical trial in patients with graft versus host disease. Additionally, the MHRA advised that Cynata’s existing program of preclinical studies is expected to be sufficient to support the approval of the proposed clinical trial, and that no additional preclinical studies are required. The MHRA also agreed with the general design of the proposed clinical trial.
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