Intellipharmaceutics International Inc. (IPCI)

[AngeloFoca]

The uptick in ANDA approvals and rejections for the latest fiscal year is thanks to almost 1,000 new employees that FDA was able to hire because of the Generic Drug User Fee Amendments (GDUFA), which is meant to help reduce the ANDA backlog.

And those reviews and approvals may pick up even more moving forward as, according to the GDUFA I performance goals (GDUFA II negotiations have recently concluded and FDA may push to eight-month and 10-month reviews of ANDAs between 2018 and 2022), FDA this fiscal year will begin to “review and act on 90 percent of complete electronic ANDAs within 10 months after the date of submission.”

I would say that IPCI should - and probably will - reconsider it's strategy and expand the ANDA submissions as they can now become income producing quite quickly.

You know $5 million here, $10 million there... pretty soon you're talking some serious money.... what the hell... they have 5 different platforms... let's dust them off and get them producing.