We just submitted an IND - So now what?, page-4

Hi Eire2011, appreciate the feedback.

I just listened (again, think it's the third time now) to the R&D section that covers a little about the aim of 006 and indeed I was under the impression that 006's focus was only:

1) Evaluate the durability
2) Evaluate the re-treatment

but there is a 3)...to view the Bio-marker/DMOAD indications...as you said.

I always thought that 008 was a preliminary study to quickly and at high level, evaluate the biomarkers in terms of DMOAD, but 006 does mention this too. The next question (which I wanted to cover later on) is will those numbers be enough? 006 is listed at 750 patients so one could surmise that indeed it might be comprehensive enough for the FDA and to evaluate to determine the effect of iPPS in this novel area in addition to points 1) and 2) above.

The timing of 006 also is a clue in that it starts 3/4 of the way through 008 so they will have some data here which will give them confidence to proceed at a greater scale, scale enough to provide a statistically powered observation to prove the concept determined so far by 008)

This would save us a lot of time and would dovetail nicely by the time we are ready to hit the streets (err..start selling).

...it's all coming together quite nicely. Thanks for pointing this out.

My views