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Wrong, I’ve seen it happen.
You seeing some news or just joking?
Hey sharpei, glad to see you’re still with us. :). Thanks for the TA. Hoping we see a good rest of the month and a solid January effect!
Ah yes, good point. So then however long it takes to address those concerns is about when we see approval? How long has it been since that response?
Oh. Interesting. So the warning letter is NOT holding us up on the ANDA approvals?
If that is indeed the case, then I’m left to wonder why the FDA hasn’t given us approval for that first big one - Percocet or Norco from Aug 2016, whichever was first. They’ve passed their own 10-12 month deadline.
Bingo. Thanks for posting.
Well "played". Heh.
"(This space intentionally left blank. IPCI never did any HAL studies.)"
LOL.
Clearly someone didn't even read my post.
Warning Letter Recovery
"**This process can easily take a year or more because of internal corrections and the need for an FDA reinspection**"
(http://fmdic.org/wp-content/uploads/2012/05/Furr-Recovery.pdf)
The warning letter’s effectiveness depends on conscientious follow-up
"The FDA completes appropriate follow-up in approximately 97 percent of cases. Followup
may involve reinspecting the firm, soliciting documentation of corrections, or meeting
with the firm to address compliance issues. In other cases, FDA does not need to follow
up except to ensure that the firm responds to the warning letter. Follow-up inspections
frequently uncover other violations, but FDA rarely has to initiate compliance actions. **On
average, follow-up inspections take place more than 9 months after the warning letter is
issued.**"
(https://oig.hhs.gov/oei/reports/oei-09-97-00381.pdf)
Not sure what your point is?
Thanks for the numerous and positive responses, folks!
"One is glad to be of service."
Per Nasrat on the last call, the FDA performed "GMP inspection and 2 pre-approval inspections". Are these for the 2 filed ANDAs for generic Percocet and Norco??
Check my recent post for DD on the warning letter process - Elite is likely due for a resolution (closing letter) from the FDA on this soon.
Some lengthy DD I did but worth the read, IMO:
8/25/16 - Elite receives warning letter
(https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521289.htm)
Warning Letter Recovery
"This process can easily take a year or more because of internal corrections and the need for an FDA reinspection"
(http://fmdic.org/wp-content/uploads/2012/05/Furr-Recovery.pdf)
The warning letter’s effectiveness depends on conscientious follow-up
"The FDA completes appropriate follow-up in approximately 97 percent of cases. Followup
may involve reinspecting the firm, soliciting documentation of corrections, or meeting
with the firm to address compliance issues. In other cases, FDA does not need to follow
up except to ensure that the firm responds to the warning letter. Follow-up inspections
frequently uncover other violations, but FDA rarely has to initiate compliance actions. On
average, follow-up inspections take place more than 9 months after the warning letter is
issued."
(https://oig.hhs.gov/oei/reports/oei-09-97-00381.pdf)
May have struck more gold here.. This is likely more telling than anything. Another pharma received the same type of warning letter Elite did regarding postmarketing adverse drug experiences (PADE) and had a subsequent resolution. This was the only one I could find as far back as 2012:
Heritage Pharmaceuticals, Inc. 11/05/2015 New Jersey District Office Postmarketing Adverse Drug Experience (PADE) 12/28/2016
(https://www.accessdata.fda.gov/scripts/warningletters/wlSearchResult.cfm?company=&_1_issueDt=&_2_issueDt=&office=&subject=&hasResponseLetter=Both&hasCloseoutLetter=Yes&recsPerPageDef=500&Search=Search&errMsg=)
***Basically from what I can tell, this means Heritage Pharmaceuticals was issued a warning letter on 11/05/2015 for PADE as well. The "closeout date" for this warning letter was 12/28/16.***
4-1-8 - Warning Letter Follow-Up
"The issuing district or center will evaluate the response to the Warning Letter. If the response is inadequate, or if no response is received, the district or center will begin follow-up action as necessary to achieve correction. If the Warning Letter contains violations that by their nature are not correctable, then no close-out letter will issue.
If the response appears adequate, the district or center will verify that commitments have been fulfilled and that correction has been achieved, and will notify other appropriate agency units. Usually, the standard for verifying that corrections have been implemented will be a follow-up inspection. Follow-up inspections should be conducted promptly after the agreed upon date of completion of the promised corrections.
Acknowledgment Of Response To A Warning Letter
The district or center that issued the Warning Letter should acknowledge, in writing, receipt of Warning Letter responses. The district or center should save a PDF copy of the issued correspondence under the Final Outcome tab in CMS, identified as doc type = "courtesy acknowledgment correspondence".
Warning Letter responses regarding CTP Retailer Compliance Check Inspections are acknowledged with "Reply to Warning Letter Response" letters. CTP should save a PDF copy of the issued Reply letter under the "POST Action Mgt" tab in CMS, identified as doc type = "Letter of FDA's review of firm's response."
Warning Letter Close-out Letter
A Warning Letter close-out letter ("close-out letter") will not be issued based on representations that some action will or has been taken. The corrective actions must actually have been made and verified by FDA.
The district or center that issued the Warning Letter should issue a close-out letter for Warning Letters issued on or after September 1, 2009, if the violations in the Warning Letter have been adequately addressed, and the following conditions have been met:
The firm replied to the Warning Letter with sufficient information to demonstrate that any listed violations have been adequately corrected; or
A follow-up inspection shows that implementation of the corrective actions was adequate, or, based on other verified, appropriate and reliable information, FDA determines that the follow-up inspection is not needed; and
The follow-up inspection (or other appropriate and reliable information) does not reveal other significant violations.
The issuing office will evaluate the firm’s response to the Warning Letter.
Where the district is the issuing office, the following procedure should be followed prior to issuance of a close-out letter. If the district performs an inspection to verify correction, the district may, but need not, ask the center whether it has a comment or objection prior to issuing a close-out letter. If the district decides not to inspect to verify correction, and the Warning Letter required center concurrence, the district will ask the center, via CMS, whether it has a comment or objection prior to issuing a close-out letter. The center will enter any comments or objections to the issuance of a close-out letter (i.e., FDA’s conclusion that the firm’s corrective actions are adequate to address the violations contained in the Warning Letter), via the center documents tab in CMS within 30 working days. If the center requests more time, an additional 30 working days should be granted. At the end of the 30 (or 60) working day period, the district will review the center’s comments or objections, if any, providing deference to the center in areas of the center’s expertise, and, where the center has provided comments or objections, will issue the close-out letter only if consensus is reached with the center.
Districts or centers should issue close-out letters within a total of 65 working days of having the necessary information upon which to make a decision. Use the model "close-out letter" in Exhibit 4-2. The issuing district or center is responsible for ensuring that a PDF copy of the final, signed close-out letter is added into CMS.
A close-out letter does not relieve the recipient from their responsibility for taking all necessary steps to assure sustained compliance with the Act, and all other applicable requirements. If a subsequent inspection reveals problems with the adequacy or sustainability of the corrections that were taken in response to the Warning Letter, such violations would be considered serious. If FDA observes violations during subsequent inspections or through other means, we may take enforcement action without further notice.
The issuing district or center will ensure that FDA posts a notice on www.fda.gov/foi/warning.htm when a close-out letter is issued."
(https://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176870.htm#SUB4-1-1)
Hope this helps, my friends. Amazing what you can find with a little research. (Apologize if any of this was posted previously and I missed it!)
Looks like we could see a warning letter resolution anytime now but may have at most a couple more months left. Nasrat did say they believe the last FDA inspection was "favorable", that they responded to the FDA on the warning letter/corrections and they that they hope and expect all issues were addressed to the FDA's satisfaction. He states there were no further write ups on anything at this last inspection. This must have been a re-inspection that occurred recently. He also mentions that they were inspected for cGMP and 2 pre-approval inspections. (for new ANDAs??)
Listen at around the 18 min 20sec mark as well as 38-39 min mark on the audio CC replay right near the end, while keeping the research from this post in mind.
Nah, need the warning letter resolved first before we can start receiving approvals I think. I'll listen again but pretty sure that's what Nasrat said.
Oh you mean the FDA, the ones who actually issue and clear the warnings, haven't given their verdict yet? Yeah, that's correct. Elite has done their part.
Agreed. More time waiting, per usual. It does sound like they'll eventually do well with all the pending generics, but as Nasrat pointed out, they need that stupid warning letter officially cleared before those approvals can start rolling in. Will hold and be waiting in the wings in case we drop to levels not seen in several years.
Agree. Did kinda sound like they wanted to shift the focus off of Sox but it's good that several larger generic drugs and markets will be in the mix.
I would hope the followup meeting has at least been scheduled. I agree, almost certainly haven't already met with them or have specific Sox guidance for us yet.
Thanks Gman. This is definitely a question I want an answer to. That, and when will Elite be able to meet with the FDA to discuss next steps on SequestOx!
"6.Why did ELTP decide to give SunGen 50% of our ER ADF line in the "mutual" partnership to bring other (unstated) generic drugs to market?"
I never heard that. Are you sure that's the case? I was under the impression that they partnered with SunGen on additional, likely non-ADT generics such as beta blockers.
Yeah, will definitely be interesting to see how it goes. We do know that Inspiron's drug was not BE and was still approved, albeit without full ADT labeling. Need to see what the FDA says on reevaluation of all the data. Unfortunately, the FDA sucks so it'll probably be awhile before we can meet with them about it.
Not so sure about this. Filing a generic OxyContin ADT will be huge. Massive market with few competitors, if any. Others like Percocet and Norco generics, once approved and launched, *should* be solid money makers.
Do agree that they need to prove the tech with an approval, both on the IR and ER sides.
Agreed. Need to hear what the FDA says. Generic ADT OxyContin filing needs to happen soon as well as approval and launch of Percocet.
It is possible. Look at Inspiron's IR drug. Not BE and still approved.
Agreed. Need generics more than ever at this point. At least big ones will start getting approved soon.
None of those were even started a decade ago so...
Definitely agree. Given upcoming planned catalysts and pipelines, this better be the last LPC agreement and Elite should be humming on 10s of millions if not 100s of millions by 4 years' time.
I must've missed that part. What was said?
The FDA is always the question mark. I'm actually optimistic about this new commissioner after the Opana verdict. Put out shitty drugs and they'll be pulled. We already know SequestOx has excellent HAL data, just need to meet the TMax requirement and we should be good.
First one we've ever had inside a trial. He already said dosing is complete. Now it's just compiling results.
Was definitely a good call.
Yep, generic OxyContin filing coming "this quarter".
Either in next 2 weeks or within 3 months we should see that filing.
Right. So I take that to mean anything AFTER October 2016 will have the 10 month timeline and anything prior will have 12-15 months?