Replies to post #370867 on Elite Pharmaceuticals Inc (ELTP)

[kayak_wench]

Thanks what you said was what I had concluded, then digging through the transcript for Q4 found this
"There are supposed to be another drug approval in Q2 of 2022. Did Elite receive a complete response letter? No, no, we had two approvals, Doxy and Generic Sabril. Generic Sabril, I think, is what you are talking about. And of the two, only one counts toward the ANDAs that I promised we are going to come through on. Doxy does not count for that. It was left over from last year."

So the approval of Sabril ANDA counts as one of the to be 'filed' ANDAs. I suppose that is fair since to be approved it had to be filed only Elite didn't tell us because it was a partnered drug.

So based on Q3 comment of "For 2022, we have two products under review by FDA, both are licensed products co-developed with partners." I think we can conclude we have a shot at one more ANDA in the form of an approval (obviously I'm assuming no CRL) this year for a total of 2 ANDAs of the 4 he mentioned. Because it is a partner product I think it is safe to assume it is one of the substantial products because it is a partner product (why bother with the hassle of a partnership for small potatoes). I think Nasrat has made it very clear there won't be anymore.

I do think we could see 6 ANDAs filed next year because Elite has the cash to pay for the trials they are just delayed.

So we probably aren't going to see a year over year increase in revenue next year because I doubt we will have any more product in market but we could be looking at big increase in FY23 to FY24 if the Dexel Adderall, Sabril, and whatever the other substantial product in review all make it to market in FY23.