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# MannKind Corp. Message Board

• la_lost_boy la_lost_boy Feb 5, 2014 12:33 PM Flag

## 87% of companies filing NDA are approved on third try

Considering that last denial was based on an equipment change, which has since been proven to be as effective as it's predecessor, I would say odds are looking pretty good.

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• Yuuuup!

• excellent fact!!

Sentiment: Hold

• A repost of my analysis on this.

Jan 9, 2014 6:19 AM 0users liked this postsusers disliked this posts0Reply

Those are cumulative numbers, not approval rates for each round. See "BIO Analysis: Resubmissions After Third Round of FDA Review Not Worth the Effort" (google it; it will come up)

Here's some simplified math, showing (with some assumptions) that the odds of approval go down slightly each round, not down hugely as some bashers would claim, but not up as you would claim..

On first filing: 55%
After second filing 75% (another 20%)
After third filing 84% (another 9%)

Long story short, approval rates per round are approximately:

Round 1: 55%
Round 2: 43.5%
Round 3: 32.7%

Here's the math:

If we assume all manufacturers re-submit if denied the first 2 times:

Assume 100 NDA Submissions

55 of 100 approved on first submission. 450 not approved.
(55 / 100) = 55% approved on first submission

45 re-submit, and (75 - 55) = 20 are approved. 25 not approved.
(20 / 45) = 44% who re-submit are approved on second submission

25 re-submit and (83 - 75) = 8 are approved. 17 not approved
(8 / 25) = 32% who re-submit a second time are approved on third submission.

But your numbers assume that all of the applicants who were not approved on first and second levels of FDA review all applied for a third submisison.

I would bet that the real world numbers are substantially lower (ballpark guess = 50 percent drop out) which would increase the percent of third round approvals.

• Of that other 13%, how many were apparently approved (Shrekil Letter / Insider Trading) and then told to go back and show equivalency of the devices for their third kick? Then had the FDA ask them as part of that 3rd attempt to add an additiional trial that increased the potential market for the product by 900% (T2s) ?

OOG

• Too bad MNKD will be in the 13% that doesn't make it.

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