Replies to post #2207 on Chelsea Therapeutics Intl Ltd fka CHIP

[kookiekook]

Some people are making a big deal out of the delay announcement for various reasons.

First, that other PDUFAs were acted upon has no real bearing on Northera. There are 6 different Office of Drug Evaluation under THE OFFICE OF NEW DRUGS (see http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm135674.htm ). I would expect several "divisions" within each of these Offices. Only two have names that indicate they deal with a specific medical area. It is likely and probable that the PDUFA that were acted upon were assigned to other Offices. In addition, I would assume that either the division or his assistant would be required to sign off on any action, and then the specific Office of Drug Evaluation and or his assistant would need to sign, before it is sent to the Director of THE OFFICE OF NEW DRUGS for his approval and signature or his assistant. If the specific head and his assistant of any the areas was absent Friday, then proper (legal) processing of the PDUFA could not occur.

Second, the delay announcement specifically states "AN OFFICE CLOSURE", which would be consistent with the above. Remember there was a storm and even if predicted in advance, it would not be foreseeable to determine what personnel could or would make it into the office, and because a storm is short term in nature, no "emergency or back-up" procedure would be imposed.

I plan to approach Tuesday, identical to Friday, and while a decision early Tuesday would be nice from a stress standpoint, I would not be over concerned if no announcement is made until after the market closes.