Ann: CEO Presentation to 2023 Annual General Meeting, page-17

fda meeting is not just critical to the development of the heart program but to the overall funding strategy . they might discuss things like patient numbers, endpoints etc.
e.g. they could have their surrogate endpoint approved therfore reducing the anticipated timeline.
im not convinced they would be holding off the meeting so they can firstly develop new delivery and manufacturing methods.
maybe they just dont have the capacity to prepare for the meeting whilst being so focussed on gvhd.
i expect the increased production development will be funded from the partnership. from memory the ards novartis partnership included funding for the upscaling of manufacturing.
the meeting has taken ages. dont really understand how investors have been left guessing as to why. if they want to keep backpain in house they need a favourable meeting outcome for heart. reimbursement from children gvhd wont fix the balance sheet. but would certainly help if they were thinking of partnering for adult gvhd.
silviu said they want 2 years of funding moving forward. i get the feeling a smallish capital raise might be the strategy to keep things going until partnering conditions are more favourable on gvhd and heart after the next round of fda interactions.