Not necessarily ludicrous. Over the next 12 months, continuation of BioMuse, analysis of Phase 2 results, preparation and design of Phase 3 trial, meetings with FDA. Then patient recruitment for Phase 3 trial, 6 months minimum. Conduct Phase 3 trial, 12 months minimum from recruitment of last patient. Analysis of Phase 3 trial results and BLA submission, 6 months. FDA decision can take up to 6 months with priority review. So one CR to get us through Phase 3 trials, another CR for the BLA submission and, and, if BLA approved, a 3rd for product launch. A partnership will remove the need for one of these. Other areas of projected expenditure over the next few years may include trials for FA, Parkinsons (with the help of MJFF), and other related indications. It will need to be a very generous and highly favourable deal for a partnership to limit the need for a CR to just one. I hope such a partnership materialises, just can’t see it happening.
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Not necessarily ludicrous. Over the next 12 months, continuation...
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