Elite Pharmaceuticals Inc (ELTP)

[no2koolaid]

Please do not misunderstand me. I am a big believer in transparency. My point has been consistent in its grounding...fluff PRs to support the p/s are worthless and can backfire...I am certain you are aware of those mistakes, chapter and verse. This does not mean I am not suggesting there would be value in a PR. But, what might that be? Well, I did some research and shared it in another forum; but I am willing to offer it here. Though I must warn you, it is rather long...but a worthwhile read that I think you will find informative. Any observations you might make that are analogous to Elite, I would like to hear if you are willing to share...here it goes...

While there is simply no way to know where Elite and the FDA stand on resolution, I could not help but wonder what others have done in responding to a CRL and if and when they PR'd something they sought to convey to shareholders, and were the reasons similar or different. That led me to completing a little research on post-CRL PR responses over the past few years...and here is what I thought this group would find interesting...

Opko resubmitted within three weeks of receipt of the CRL and was granted a six-month review period (Class 2 Meeting) for their resubmitted NDA.
http://finance.yahoo.com/news/fda-accepts-resubmission-drug-application-164300838.html

Alexa PR’d they have resubmitted within a month of the receipt of the CRL. They were of most interest because theirs was a labeling issue.
http://www.empr.com/drugs-in-the-pipeline/nda-resubmitted-for-adasuve-for-agitation-in-schizophrenia-or-bipolar-i-disorder/article/246918/

Adams resubmitted after re-design of product. Adams took approximately five months to re-engineer the design of the product, manufacture prototypes, and test the new design, before resubmitting, as it related to a device not a drug.
https://globenewswire.com/news-release/2016/01/14/802135/0/en/Adamis-Pharmaceuticals-Announces-FDA-Acceptance-of-Resubmission-of-Its-Epinephrine-Pre-Filled-Syringe-NDA.html

Aralez released a PR BEFORE resubmission was finalized. They indicated the FDA is expected to issue Aralez an acknowledgment letter within 30 days of resubmission as to whether the resubmission addresses all the deficiencies identified in the CRL. If accepted, this acknowledgement would also include a new Prescription Drug User Fee Act ("PDUFA") date.
http://www.prnewswire.com/news-releases/aralez-resubmits-to-fda-new-drug-application-for-yosprala-300235999.html

Orexigen resubmitted two years after the CRL due to the need for new study.
http://ir.orexigen.com/phoenix.zhtml?c=207034&p=irol-newsArticle&ID=1883850

Other situations:
AcelRx PR’d their plans to meet with the FDA to discuss and clarify the agency's belief that an additional clinical study is needed, and the potential design and objectives of such a study. As a result of this FDA communication and the need for clarity from the FDA, AcelRx will not be making the Zalviso NDA resubmission this quarter. AcelRx will provide an update on the timing of the resubmission of the Zalviso NDA after AcelRx obtains more information from the FDA. The Complete Response Letter received by AcelRx in July 2014 in response to the Zalviso NDA contained requests for additional information on the Zalviso System to ensure proper use of the device.
http://news.acelrx.com/phoenix.zhtml?c=241441&p=irol-acelrxnewsArticle&ID=2023704

Interesting issue of a second CRL issued to a company that was related to an FDA failure! (I mentioned this yesterday)...
Drugmaker Pozen (POZN) says its API supplier has done everything the FDA asked after noting issues in an April plant inspection that led to Pozen getting a complete response letter (CRL) for two cardio drugs. Changes were made, the FDA was updated and an expert agreed things looked good, so the company resubmitted its application in July. But the FDA's compliance division has been too busy to get back to the plant and see for itself, and so the agency has sent Pozen a second CRL with "identical wording."
http://www.fiercepharma.com/drug-safety/pozen-gets-a-second-crl-as-its-api-supplier-awaits-fda-reinspection

Arena PR’d an end of review meeting BUT before actually resubmitting
SAN DIEGO and WOODCLIFF LAKE, N.J., Dec. 22, 2010 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. announced today the completion of an end-of-review meeting with the US Food and Drug Administration (FDA) for the lorcaserin New Drug Application (NDA).
"The meeting discussions reinforce our position that we have a path forward to seek FDA approval of lorcaserin," said Jack Lief, Arena's President and Chief Executive Officer. "Based on guidance we have received from the agency, we are executing several activities and expect to resubmit the lorcaserin NDA by the end of 2011. As we continue discussions with the FDA to refine elements of our plan, we may identify ways to shorten this timeline. We will provide more details about our plan on the conference call and webcast this morning."
Arena submitted an NDA for lorcaserin to the FDA in December 2009, and the FDA issued a Complete Response Letter (CRL) in October 2010. In the CRL, the FDA outlined non-clinical and clinical reasons for its decision and provided recommendations relating to addressing such issues. The end-of-review meeting with the FDA included a discussion of the FDA's position on issues identified in the CRL and Arena's plan to respond.
http://invest.arenapharm.com/releasedetail.cfm?ReleaseID=538430

Finally, there is this from the Motley Fools…
Food and Drug Administration review times usually offer little in the way of a hint at the likelihood of approval. Sometimes drugs are given a priority review because they treat an unmet need and then get rejected: Dendreon's (Nasdaq: DNDN ) Provenge the first time, for instance. Review times get extended and some drugs still get approved -- Pfizer's (NYSE: PFE ) Preener 13 and Human Genome Sciences' (Nasdaq: HGSI ) Benlysta, for example -- while others get a thumbs down: Merck KGaA's cladribine, for example. The one exception: The FDA classifying a company's response to a complete response letter as a class 1 response. The response comes with a two-month turnaround instead of the standard six-month response for a class 2 response. The FDA issues a class 1 response because the resubmission is for something minor: a labeling issue, commitments to do post-approval studies, "minor" clarifying information and the like. There are no guarantees for an FDA approval, but minor issues are usually easily cleared up. So it isn't all that surprising that Transcept Pharmaceuticals (Nasdaq: TSPT) shot up 34% yesterday after announcing that the FDA had classified its resubmission as a class 1 response.
http://www.fool.com/investing/high-growth/2011/10/05/1-sure-sign-of-an-fda-approval.aspx

This makes a Class 1 response clearly preferable because it allows for a 2 month response versus a 6 month response. The one disconcerting aspect in making that decision (unless a simple labeling issue), the FDA can decide on a Class 2 response IF THEY BELIEVE THERE IS A NEED FOR AN ADCOM.


N2K