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Biotech / Medical : Rockwell Medical Technologies (RMTI, RMTIW)
RMTI 1.090-2.2%3:59 PM EDT
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To: Bert Herman who wrote (29)1/22/2005 8:17:05 AM
From: scott_jiminez   of 34
 
Bert - I was referring to final FDA approval for use in the clinic.

You are correct in that the pre-clinical studies are now under FDA review and that upon completion of this the protocol for the formal clinical studies will be submitted. At this point clinical studies will begin.

The dialysate iron concentrate received FDA product classification as a "combination product" for the approval process going forward. The allowed submission is a unique embedded classification (drug within a device).

My take is that since the company has the entire infrastructure at (or near) its disposal for the clinical studies - especially since Rockwell's close relationship with DaVita, the largest dialysis provider on the country, provides a huge potential patient pool - that the completion of the clinical studies most likely will be expedited and thus be could be completed in less than a year.
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