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Solid post.
Nope, the real one.
Just because the stock price hasn’t hit the higher numbers listed in the valuation does not mean that the methods used, or the numbers derived, were wrong.
No worries. All 3 will be significant approvals for Elite.
I thought the hard shell was used in the generic Oxy ADT.
Yessir. Took a little digging but still there in historical posts. Looks like a class II resubmission.
Indeed. May tip back a Dos Equis tonight to honor our old comrade as well. Cheers, R.I.P. Lasers.
Welcome! Good first post.
What was your impression of the SunGen exec at the time?
Some 2016 info I posted and gathered from my own and others’ DD:
Re: RLSJ84 Post# 215531
https://www.gpo.gov/fdsys/pkg/FR-2008-07-10/pdf/E8-15608.pdf
TABLE 1.—SUMMARY OF CHANGES REGARDING SUBSTITUTION OF COMPLETE RESPONSE LETTERS FOR APPROVABLE AND
NOT APPROVABLE LETTERS
Complete Response Letter
• States that FDA will not approve NDA or ANDA in its present form.
• Describes all specific deficiencies that FDA has identified in the application
(except when the agency determines that data submitted
are inadequate to support approval and issues a complete response
letter without first conducting required inspection and/or reviewing labeling).
Deficiencies could be minor (e.g., requiring labeling
changes) or major (e.g., requiring additional clinical trials).
• Reflects complete review of data in NDA or ANDA and any amendments
FDA has reviewed.
• When possible, recommends actions applicant might take to place
application in condition for approval.
TABLE 2.—SUMMARY OF CHANGES TO REGULATIONS REGARDING APPLICANT’S RESPONSE TO AGENCY ACTION LETTERS
NDA or ANDA Applicant’s Response to Complete Response Letter
Review period is extended until applicant takes one of following actions:
• Resubmit NDA or ANDA, addressing identified deficiencies.
—Class 1 resubmission of NDA or efficacy supplement starts new 2-
month review cycle
—Class 2 resubmission of NDA or efficacy supplement starts new 6-
month cycle
—Resubmission of NDA supplement other than efficacy supplement
starts new cycle same length as initial review cycle for supplement
(excluding any extension due to major amendment)
—Major resubmission of ANDA or ANDA supplement starts new 6-
month cycle
—Minor resubmission of ANDA or ANDA supplement starts new cycle
of variable length
• Withdraw NDA or ANDA.
• Request opportunity for hearing.
FDA may consider failure to take action within 1 year to be request to
withdraw, unless applicant has requested extension of time in which
to resubmit.
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM082002.pdf
Applicant submits a response to a Complete Response Letter (CRL)
FDA determines whether or not the response is complete and responds in a letter to the applicant within 30 calendar days
If FDA determines the response is NOT complete CDER so informs the applicant and the review clock does not start until a complete response is received.
If FDA determines that the response is complete, it will be classified as Class 1 or Class 2
If the CRL is classified as a Class 1, CDER will complete the review and act on the application within 2 months of the receipt date
A Class 1 classification includes
Final printed labeling
Draft labeling
Safety updates submitted in the same format, including tabulations, as the original safety submission with new data and changes highlighted (except when large amounts of new information, including important new adverse experiences, not previously reported with the product are presented in the resubmission)
Stability updates to support provisional or final dating periods
Discussions of postmarketing requirements/commitments, including proposals or protocols for such requirements/commitments
Assay validation data
Final release testing on the last 1 to 2 lots used to support approval
A minor re-analysis of data previously submitted to the application (determined by CDER as fitting the Class 1 category)
Other minor clarifying information (determined by CDER as fitting the Class 1 category)
If the CRL is classified as a Class 2, CDER will complete the review and act on the application within 6 months of the receipt date
A Class 2 resubmission includes any item not specified as a Class 1 item, including any item that would require a presentation to an advisory committee. A resubmission that requires a reinspection also would be a Class 2 resubmission.
And some massive market ANDAs will be approved and launched in the meantime. Cheers!
So this means we have succeeded in in-vitro and have now succeeded in initial in-vivo testing, correct?
I don’t think so. If I remember correctly, resubmissions are based on the type. I wanna say 6 month FDA response time based on Elite submitting new SequestOx data but I’d have to pull up old posts to confirm.
There was doubt that the warning letter would be resolved too. Took a little while but it’s cleared. Same will happen for the ANDAs. FDA is sloooooow.
I agree with most of this but 1 question - does Nasrat really own 51% of the shares? I thought he had ~150-160M of almost 800M total.
From another source:
I think they have 36 months to show usage per uspto manual. 5 extensions of 6 months each. This might have just been a judgement call that they cannot show usage before the 6/09/18 deadline. Saves the last possible extension fee. Just need to pay a new 2K or so once they get approved.
https://www.uspto.gov/sites/default/files/documents/BasicFacts.pdf#page30
Cool, appreciate the link. Yes, unfortunate that approvals will slow but at least they won’t stop completely. Let’s hope Congress can work this out sooner than later.
You’d prefer a fake company with an artificially high stock price vs the opposite?
Agreed, just keep bringing facts and links. They are indisputable.
Thought the huge majority of gov services continue. I’d have to assume the FDA is in that majority.
They aren’t capturing any of the market because they aren’t approved or launched yet, so there’s that.
Huh?
“Because ELTP has agreements with SunGen for minor drugs”
#fakenewsawards
Elite Announces Development And License Agreement With SunGen Pharma LLC
“For the twelve months ending June 30, 2016, the four products and their generic equivalents had total U.S. sales of more than $3 billion according to IMS Health Data.”
http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=82294&GoTopage=1&Category=2163&BzID=2258&t=2054&G=939
Elite Announces New Development and License Agreement with SunGen Pharma LLC
“For the twelve months ending March 31, 2017, the five products and their generic equivalents had total U.S. sales of more than $2.5 billion according to IMS Health Data.”
https://globenewswire.com/news-release/2017/07/12/1042976/0/en/Elite-Announces-New-Development-and-License-Agreement-with-SunGen-Pharma-LLC.html
#facts
Just checking in again, still no proof they won’t partner up with a larger company I see. Thanks again for confirming! LOL
No proof that there won’t be? Cool, thanks for confirming.
So no proof, thanks for confirming.
Any proof they won’t?
Because they’ll likely partner with larger companies who CAN penetrate those markets.
Conix, just about every drug that Elite has ever gotten approved thus far and is currently selling are in markets that might be considered “peanuts”. There aren’t any multi-billion dollar products (or even several hundred million dollar products) that they have even gotten approved yet:
Hydromorphone 8mg tabs - $30M
Naltrexone 50mg tabs - $16M
Phentermine 37.5mg tabs - $40M
Isradipine 2.5 & 5.5mg tabs - $5.5M
Hydroxyzine 25 & 50mg tabs - $40M
Phendimetrazine 35mg tabs - $4.5M
Trimipramine 25/50/100mg tabs - $2M
Let’s be intellectually consistent here. Let them get a big ANDA approved and selling and THEN if they can’t penetrate that market in any meaningful way, your criticism will be justified.
Pending approval:
Oxycodone ADT - $2.3B
Hydro/APAP - $700M
Oxy/APAP - $700M
Undisclosed pain product - $40M
I meant to go back and listen to 1 or 2 CCs last night but forgot.
Do we know which ANDA should be furthest along, considering CRL response times and ones where the FDA had no objections to our filing?
How is that statement misleading? It’s factually true and doesn’t say anything about Elite.
You are correct on market penetration, what market share Elite can garner remains to be seen. But that doesn’t change the markets those ANDAs are in, and you make precisely $0 in those markets with ANDA approvals.
Not go it alone for sure. Epic/Puracap or Dr. Reddy’s, IMO. Get a solid base of 1 or 2 of these heavy hitters and then maybe go solo or with a different partner for better profit split.
Still doubting Elite’s ability to get standard ANDAs approved? Lol
Let’s hope that ELTP spidey-sense is on point!
MiFid II? Haven’t kept up with industry news much lately.
Lol have to agree. Needs to extend the deadlines out and start hitting them. Surely we see 1st SunGen product in the next week or two. At least we know with the trial PR that they are working on multiple products simultaneously.
Should be easy to repost then. We’ll wait.
And that one?
“Can’t trade premarket” yet I see a 100 share trade today for .1480 already. EXPLAIN IT.
Some big ask slaps. 130k, 100k, 54k, 40k....