Replies to post #299088 on Elite Pharmaceuticals Inc (ELTP)

[Jimmy Joe]

The important thing to remember here is: has Elite addressed the CRL issue? Yes Elite has addressed this issue.

NH said after the first reformulation attempt that Elite would attempt to reformulate again. IF the reformulation was successful Elite would go on with SequestOx. Pilot study shows that the reformulation was indeed successful. Elite is going forward with SequestOx. Pilot study submitted to the FDA. Elite awaits a response back.

[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