My understanding is that the transition to 3D will be...

My understanding is that the transition to 3D will be progressive. Bovine free first then moving on to 3D and it will take a lot of clinical work, not clinical trials.

This is were the major delay is. Proof of a consistent and effective product as we develop manufacturing. SI believes that we now have what is necessary, that is why he is meeting with the FDA department.

No matter how much proof SI has there will always be some remaining doubt , any changes wether accidental or deliberate could change our cells and no matter how much testing is done it may not show up.

We have recently seen a major study of results for Temcell in Japan . There no reason why such studies could not be mandated in the US and continually monitored to insure safe and effective product, may even become better at the job that it is intended for as our past developments have shown to be. We may even find that certain batchs are better for different people and potentially different indications. Variables between batches is not a disadvantage , it is going to be a very big advantage over a product that never changes.

So given that real world studies are likely to be mandated and continually monitored is batch to batch consistency that important when patients are dieing.

Remestemcell-L is effective. Sort out the procedure and we have market access. SI is on the job.

Good luck all.