Couple of bag-holders still in this I think. I hold a little IRL no on SM. Could be a good sign:
Dear investor,
We are pleased to announce that a Certificate of Analysis (CoA) has been issued by Ardena for the first current Good Manufacturing Practice (cGMP) batch of our proprietary bisantrene formulation, RC220, confirming that the drug product meets the quality specifications required for human use.
Our innovative RC220 formulation has been designed to enable safe administration of bisantrene to patients via peripheral vein (arm or leg) intravenous (IV) infusions. The CoA confirms that RC220 meets the manufacturing quality specifications required for IV drug products to be used in humans. Adherence to cGMP quality standards meets the requirements for evaluating new IV drug products in human Phase 1 & 2 clinical studies in Asia-Pacific, Europe and the USA.
Reaching this point in the development of bisantrene is a major milestone and is a testament to the dedication and skill of the Race team. We are now looking forward to completing the GLP toxicology testing of RC220 in the coming months and beginning the clinical program that will give patients access to bisantrene in a format that is both easier and safer to use.
For more information, please refer to our ASX Announcement here.
Best Regards,
Dr Daniel Tillett
Chief Executive Officer