is this why fda delays are getting longer?, page-14

Interesting Jessie1,

ACL's announcement 11 April;

"....Multiple site inspections were completed successfully with
the most recent one completed in January this year. As a result, the Company expects there to be no further
procedural impediments required prior to approval. Alchemia anticipates the next communication from the
FDA to be the product approval itself...."

The Multiple site inspections reference is interesting. There seems to have been more than one inspection. No free flowing information about the site inspections unfortunately. So ..did the scheduled Nov 2010 inspection take place? was there a subsequent inspection prior to the early Jan 2011 inspection?

IMO there were issues that the 3rd party and possibly DR had to address and we have not been told what these issues were and how these issues were addressed in mid Jan 2010 through corro from DR ? to FDA.

We have no information re these issues and no information re DR response so we are in the guessing game rather than being informed.

My question is.. where does disclosure to shareholders start and third party confidential end?.

Is the FDA really to blame for the delay, or were those issues that the FDA required DR and the third party to address the reason for the delay in approval?

Just putting it out there!

After all it is mid April .. 3 months after final submissions in mid Jan.