"The future of stem cell therapy is MSB"
Yes, first to market "maybe" just like the Motorola brick....awesome! Osiris!
I'd be focusing on your own glaringly obvious FDA issues right now....like the cost of new trials and the inventory buildup + US sales staff salaries with no product to sell and how many more millions to spend again before revenue.
and do say a big hai to Wombat for me. A$1B NPAT FY21....lol (oh, that's right, he's totally left your threads now).
Also, I picked up something in your annual report on the magic 3D bioreactor "project" . Barman and Benelong claimed it's all ready to go. We trust in SI......well, well.
"To date our product candidates have been manufactured in two-dimensional, or 2D, planar, 10-layer cell factories, using media containing fetal bovine serum, or FBS. The relatively small patient numbers and orphan drug designation for RYONCIL lead us to believe that 2D manufacturing will be adequate to meet demand for this product candidate if fully approved. We also believe that 2D manufacturing process and facilities are commercially feasible for Phase 3 trial supply and the initial launch of MPC-06-ID for CLBP.
However, to build up commercial supply for certain of our product candidates long-term, we are developing novel manufacturing processes using three-dimensional, or 3D, bioreactors with greater capacity to improve efficiency and yields, with resulting lower-cost of goods. We intend to evaluate products produced in 3D bioreactors in pre-clinical and potentially clinical studies, which may serve as FDA required comparability studies to 2D if successful.
We are also focusing on the introduction of FBS-free media which has the potential to result in efficiency and yield improvements to the current 2D process. We intend to conduct comparability studies to illustrate that products produced with this media are equivalent to those produced using FBS based media. While we remain confident in our ability to deliver successful outcomes from each of these activities, any unexpected issues or challenges faced in doing so could delay our programs or prevent us from continuing our programs."
chew on that one for a bit would ya.
we won't be making the same mistakes.
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