7 May release
“well advanced “ over 2 months ago !!!!
“The Company has proactively solicited and evaluated a number of CMOs who specialise in the formulation of peptides for clinical and commercial purposes. Several detailed proposals have been received for the manufacture of PresendinTM for late-stage clinical trial purposes and commercial supply which meet the stringent regulatory requirements of the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) pertaining to the manufacture and supply of human therapeutics under cGMP.
The Company has also undertaken detailed additional analyses relating to cost per unit at commercial scale volumes and potential pricing structures, taking account of market access dynamics such as government/private payers and overall patient acceptability, which is important when committing to long term manufacturing/supply agreements.
The proposals and contract discussions are well-advanced and in the process of further legal and commercial review. Invex will update the market once the manufacturing selection process has been completed and a binding manufacturing agreement signed.”
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