Repost from Ecoool Turtle about todays quarterly:Excellent news...

Repost from Ecoool Turtle about todays quarterly:

Excellent news today. Operating cash burn below the budgeted $US12m per Q.

Sound confident re approval of aGvHD for kids. More detail on what FDA actually said. Decision to drop adult trial and go for label extension instead shows a clear confidence that kids approval is coming and will save $US5-10m in trial costs, also means cells in inventory can be used on paying paediatric patients rather than in the adult trial which allows faster treatment of kids and saves more cash. Also means they can concentrate more resources on the back pain trial which is a potential blockbuster and should be the priority.

Timelines are intact. File aGvHD BLA this quarter, approval in H2 2024. Back pain trial "underway". FDA said LVAD results may support accel approval - expect a pre-BLA meeting with FDA to discuss timing and data required for AA filing.

Cash at 31 March $US76m after paying down $US10m in debt which also reduces the cash balance requirement by $US10m - so doesn't affect how we have been calculating net useable cash and implies comfortable with cash runway in choosing to pay down debt.

I wait to hear from the new Chair what her plans are, but it's clear that GG's Board rep now has a lot more influence. I expect that means the missteps of the last CR won't be repeated. GG won't want to see dilution in the future now that he has built a controlling stake.

High cost of dilution, but now in a much stronger position with FDA and financing.