Elite Pharmaceuticals Inc (ELTP)

[no2koolaid]

Chasing, you are close but the number is a couple of percentage points higher. Still, it would serve Elite investors well if I post the specifics once again...

According to the FDA, for all drugs of all types submitted, the average approval rate is 55% for the initial submission...which means 45% a received CRL.

Upon second submission, we find that 77.6% of the first submittals are now being approved (22.6% more). Notable because this is where Elite finds itself...making a second submittal.

For those receiving a second CRL and resubmitting a third time...we find the number of original submittals improved to 82.9%.

After the third CRL, the approval percentage diminishes and it appears the question becomes one of management’s ability to attend to what the FDA is asking or if there is a question about the real benefit of the NDA as determined by the FDA. Nonetheless, for those who are persistent in their efforts, after a third CRL, with a subsequent fourth submission, there is an approval rate of 84.3%.

Despite having received a CRL, that means a notable 53.3% more of the initial NDAs get approved over time. Proving that companies listen and fix their problems. Here is the math: 84.3 - 55 = 29.3 / 55 = 53.3