Replies to post #378285 on Elite Pharmaceuticals Inc (ELTP)

[The ELTP King]

DAM you're good...

My goodness...

Hi all, just wanted to give my quick input as well as condolences for N2K, he will be deeply missed. The quota for controls has nothing to do with the FDA and is handled by the DEA, the biggest issue as everyone is seeing with teh shortages was that the DEA adjusted annual quotas down for the past 2-3 years because of the opioid abuse, now you are seeing the repercussions, they are going to be hesitant to increase it as now everyone is watching things under a magnifying glass and pointing fingers. The entire blame for all of this mess is the DEA but no one can go after them, untouchable.
Elite has to file Form 250 by April 1 asking for 2024 quota based on historical sales and previous quotas and can usually add 10% to previous years. So in theory Elite already has all of 2023 quota approved, Lannett not so much if they got any at all. Yes Lannett needs to file as a new company and will not get a large amount as they have no manufacturing history nor quota history for this compound, this is if the DEA even gives them quota as there is a shortage. We have seen them deny quota to new companies when the demand is this bad. Just wanted to give everyone a little context. Hope all is well with everyone. Russ

Deadlines
Annual applications for quotas must be filed on or before the date indicated of the year preceding the calendar year for which the quota is being applied.

DEA Form 189 for Manufacture Quotas must be filed on or before May 1.
DEA Form 250 for Procurement Quotas must be filed on or before April 1.
DEA Form 488 for Import Quotas must be filed on or before April 1.

[kayak_wench]

Thank you Winechemist, but how do you reconcile with what you say will happen with what Elite said on the last CC about having a dip because it was unable to get additional quota to get 'their product' manufactured ahead of time. Nasrat did say they had to give Lannett everything they manufacture. But I don't see the reason for the 'dip' because if Elite gives them drugs Lannett has to pay them for it so there shouldn't be any dip in revenue. The only way I see a dip is if there is a period where Elite doesn't get the material to make pills and it goes a few months with shipping zero Adderall.

Also, how does Elite intend to support large new orders from Europe with only 10% extra in quota. I recall Elite saying they could sell more if they could be allowed to make more so it sounds like they were already using their full amount.

[imanjen13]

Thanks Russ.
If I understand the DEA application process, it would appear that form 250 filed last year by elite, granted them a quota for the entire calendar year ending December 31, 2023, so that the nine nine months left for the year for Elite to manufacture and distribute its own Adderall has already been established. The only unknown for this year would appear to be the amount of API Elite can and is able to procure to make the stuff. Is this assessment correct?

Apparently, the shortfall, which NH suggested would occur for the April-June quarter, was the result of the fact they had to continue to supply Adderall to Lannett up to March 31 and therefor would not have enough manufacturing capacity and time to produce the quota allotment for its own distribution during the quarter. Question. Can Lannettt sell product manufactured by Elite delivered up to April 1 as their product and screw Elite out of the profit from the deliveries they make after March?

Your clarification is appreciated.