Dendreon Corp fka DNDNQ

[artavia2007]

I originally posed this query to Dew on the IV mb, but received no response. Dew, since I think you mostly hang out here on IH, decided to post it here. My thoughts are sincere. Though addressed to Dew, I'd like feedbck from whomever's willing to throw their US$.02 into the ring.

I've seen a great deal of to-n-fro concerning efficacy points, TTPs, p-values, etc. in relation to discrepancies and points of contention regarding Provenge's scientific data and trials. As I thoughtfully consider both sides ("it's proven to work" vs. "not enough proof"), I find it interesting that of the 6 choices the FDA had at its disposal to issue to Dendreon (Approval, Approvable, Major Deficiency, Not Approvable, Denied, Abandonment), the FDA chose and issued an "Approvable", based on its scientific review of the data. Obviously disappointing when compared to an "Approval" - but perhaps also illuminating when compared to its next choice for going against an Approval, which is that of Major Deficiency. So the FDA determines an Approval is not warranted; as such, it must pick from the other 5 choices to address its non-approval, and chooses Approvable - NOT Major Deficiency. Why would that be? If the science is as filled with holes, inconsistencies, lack of proof, etc. as has been articulated by many, why would the FDA choose an Approvable and not a Major Deficiency?

Personally, I found the wording and comparisons between those two choices very interesting:

http://www.fda.gov/cdrh/mdufma/guidance/1218.html#_Toc47768482

B. Approvable Letter
1. Definition
An approvable letter informs the PMA applicant that FDA has completed the scientific review of its application and determined that the PMA can be approved pending resolution of minor deficiencies identified in the letter or during FDA's inspection of the device's manufacturing facilities. (21 CFR 814.44 (e))

2. FDA's Criteria for Issuing the Approvable Letter
FDA should issue an approvable letter once:

a. FDA has determined that there are remaining minor deficiencies(6) that must be answered before FDA can issue an approval order. (The minor deficiencies are specifically identified in the approvable letter.)

and/or

b. FDA has not yet determined whether the applicant's manufacturing facilities, methods, and controls are in compliance with the Quality System Regulation (QSR) as required under 21 CFR Part 820.
_________________
(6) Minor deficiencies are clarifications of previously submitted information.

C. Major Deficiency Letter
1. Definition
A major deficiency letter informs the applicant that its PMA lacks significant information needed for FDA to complete the scientific review of, and render a final decision on, the PMA. (21 CFR 814.37(b))

2. FDA's Criteria for Issuance of a Major Deficiency Letter
A major deficiency letter should be issued once FDA has determined that the PMA lacks any of the following necessary data:

a. detailed re-analysis of previously submitted data (e.g., alternative statistical method);

b. additional test data needed to demonstrate safety and effectiveness of the device (e.g., electromagnetic compatibility, electrical safety,; biocompatibility, reliability, software, labeling, animal testing, sensitivity and specificity in a certain population);

c. scientific justification for test data (method and acceptance criteria) provided in the submission;

d. new validation data and analyses (e.g., due to device modifications made during the course of the PMA review); and/or

e. any other substantive deficiencies that prevent FDA from making a determination about the device's safety and effectiveness.

In point, I find the negative commentary towards the drug's scientific credibility and value very puzzling. My question: What can one infer by the FDA's choice of "Approvable" when compared to "Major Deficiency"?

Thanks for your thoughts.