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Nasrat Hakim has a home in Parkland, FL. I would imagine that office space is close to his home there and was primarily used during COVID.
No more like .09. $5 is in a couple years though.
This is very good news for Elite. Perhaps the best in years. What should not be overlooked is that while the lifting of the warning letter is important, the 12/4 pre-approval inspection is far more significant. A pre-approval inspection is performed to contribute to FDA’s assurance that a manufacturing establishment named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete. It is the final step before an approval of an application.
Elite currently has five generic products pending FDA approval.
-Oxycodone Hydrochloride ER with ADT OxyContin ADT
-Oxycodone Hydrochloride and Acetaminophen, Percocet
-Hydrocodone Bitartrate and Acetaminophen, Norco
-Undisclosed Generic Undisclosed - Pain
-Undisclosed Generic Undisclosed - Bariatric
The inspection was classified as “No Action Indicated” (NAI).
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ucm073059.htm
NAI - No Action Indicated. No objectionable conditions or practices were found during the inspection.
We should be seeing an imminent approval of one of these filings.
WeeZuhl did you pass this: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124579915 info along to investor relations at Elite for internal dissemination?
That is categorically incorrect. Pfizer lobbying breakdown by year: https://www.opensecrets.org/lobby/clientsum.php?id=D000000138
Thanks
Thanks Lasers. Where is the press release noting what types of drugs they are? There is nothing on Elite's website or in the filings.
Best bet one of these is clopidogrel (plavix).
Advancement of Ascendia Pharmaceutical's Nano-Emulsion Technology Platform with Its Lead Development Program ASD-002 - http://www.nanowerk.com/nanotechnology-news/newsid=37215.php
Ascendia Advances, Successfully Applies Nano-Emulsion Technology Platform -
http://www.drug-dev.com/Main/Current-News/Ascendia-Advances-Successfully-Applies-NanoEmulsio-1118.aspx
Patents Inassignee:"Jingjun Huang"
https://www.google.com/#tbm=pts&hl=en&q=inassignee:%22Jingjun+Huang%22
That's correct, Sungen was incorporated last year: http://www.bizapedia.com/nj/SUNGEN-PHARMA-LLC.html
Jim Huang: https://www.linkedin.com/in/jim-jingjun-huang-ph-d-36881114, who founded Ascendia Pharma: http://ascendiapharma.com, and is currently CEO, also started Sungen.
When Robert Califf was appointed, the FDA was basically handed over to big pharma. That being said, Califf cannot afford another "60 minutes" Duke type scandal or he is toast. Furthermore, he has been charged to help the FDA with the opioid epidemic not get caught up in something this sinister.
Elite may be a small pharma company but they have enough highly connected folks on board to make a stink at a very high level. If there is a calculated nefarious plan on the part of the FDA to squash Elite it will be made public and will lead to significant problems for Califf.
I did not see anything yet that would work with Elite's ADT tech. I imagine this is a generic for the purpose of generic revenues.
Because he can sell the product(s) to Elite in a matter that works in the best financial interest for Elite. We will know what drug(s) within 10 days the Teva deal closing which is imminent now that the FTC has approved.
Best guess would be Fentanyl Buccal (generic of Orexo's Abstral) which went off patent last year. Just thinking about the fact that Actavis filed an ANDA and then Orexo filed patent infringement litigation which they settled last October. I still believe Actavis and Hakim are attached somehow and Mikah is just ingenious "non-affiliated" subsidiary. It's a sublingual tablet though so not entirely sure.
Buprenorphine could be a sleeper candidate. Is there a list available of what both companies currently have. If so, could hone in a bit more.
Do you have any thoughts?
The drug(s) purchased by Mikah in the divestiture would have been in process for awhile, prior to any knowledge of the CRL coming. This happens under the oversight of the FTC. The acquisition is in the final stages of closing. It takes months for the process to play out. We are talking about $1B in divestitures (the biggest in history). As soon as Teva closes, the divestitures must be completed within 10 days. One must assume that Hakim has secured something positive out of the 79 options for Elite. This could be very interesting.
Study should take 4 weeks. Here within 2 months.
What a relief. This is the best possible news that could have emerged from the CRL. Mini trial and then approval.
No every prescription written by clinicians is tracked in addition to caps on how long you can write an opioid rx for.
Lasers - Anything rx sched II and over is monitored and reported weekly to a centralized database for each and every prescriber in CT.
SequestOx will be approved with labeling this week. Not sure where you are getting your information.
So now you think SequestOx will be approved? I agree. SequestOx will get nasal and IV ADT labeling without a doubt. I do not believe oral ADT is possible with the current ADT delivery systems out there, so that is a moot point.
Friday's approvals out. http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm. Look for Elite to be on this shortly.
That's correct. Elite, prior to filing their application, met with the FDA to go over everything the FDA would want. They even ended up doing additional trials they were not expecting to have to conduct. The Priority Review is key here... Look at the approval rate of Priority Reviews. Seldom does an app with Priority Review not get approved. Elite provided the FDA with everything they needed, including flawless data, and got Priority Review. That coupled with no ADCOM set, is telling. Approval is in the bag. This is singlehandedly the most important week in Elite's history. 11 years after buying my first shares of ELI, it is clear now that Elite has finally arrived. A lot more people are going to find out about this company starting this week.
Yes. In my opinion Elite received word from the FDA already and we should see a formal press release from Elite before market opens on Wed or Thurs of this week.
The FDA does occasionally PR an approval but very rarely. Elite's approval will be pushed live to the following FDA webpage: http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm. However, Elite will have likely PR'd approval themselves prior to it getting on that FDA page.
This is the typical timeline.
Elite will know approval status 3 business days via fax or secure email to the single regulatory point of contact at the company prior to the FDA publicizing the approval.
The FDA sends a copy of the signed approval or tentative approval letter, with any enclosures and confirms receipt of the letter.
If a press communication has been prepared the FDA press office will be notified as soon as receipt of the approval letter has been confirmed by the applicant.
Within one business day of approval, the FDA will issue an e-mail to the CDERAPPROVALS distribution list to notify appropriate personnel of the approval and the FDA Division of Online Communication (DOC) will publish on the FDA website on the following day.
I have to disagree. This approval next week validates Elite's technology which is applicable to a entire suite of opioid products. That single handedly takes much of the risk that those investing pre-approval had to take into account off the table and will inevitably change and strengthen the investor pool. A lot more people -- who have never heard of Elite -- will start to find out about this company over the next couple weeks.
Additionally, approval adds significant value as it relates to acquisition cost. Elite is worth billions in acquisition costs starting next week.
Lasers -- elite will know well in advance of it being posted on this weeks approvals.
Elite will know approval status 3 business days via fax or secure email to the single regulatory point of contact at the company prior to the FDA publicizing the approval.
The FDA sends a copy of the signed approval or tentative approval letter, with any enclosures and confirms receipt of the letter.
If a press communication has been prepared the FDA press office will be notified as soon as receipt of the approval letter has been confirmed by the applicant.
Within one business day of approval, the FDA will issue an e-mail to the CDERAPPROVALS distribution list to notify appropriate personnel of the approval and the FDA Division of Online Communication (DOC) will publish on the FDA website on the following day,
Also, this isn't a good example.
The FDA wanted clearer directives on how clinicians would be educated on the delivery system.
Implanting rods in the skin, and knowing how many to insert, is a little more complicated than directing a patient to take a pill with water.
Titans Probuphine was approved. It's in market now?
Lasers - it's very bad right now. I moved to New Haven last winter and have seen exponentially more fentanyl cut heroin overdoses than before. We used to see pts presenting with fentanyl overdoes who thought they took oxy but it was in fact fentanyl. This is entirely different from a scale and scope perspective.
Senderos -
FDA gave Elite a PDUFA date of 7/14 which is roughly a six month review period. Theoretically one would deduce that in the initial stages of the FDA review -- after ensuring they have everything they need in the application to begin the formal review process -- they would decide whether or not this needed to go through a ADCOM vote. The logical committee to review Elite's technology and data would be the same one that met last week re: Pfizer and Teva (Anesthetic and Analgesic Drug Products Advisory Committee).
They don't meet again until September: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm414515.htm
It makes no sense why Elite would not be included in those meetings given the timeline of this reviewing period because the FDA would have known they needed to get Elite's application in front of the committee.
Furthermore, the FDA is getting pushed like they never have to a) make approvals in a timely fashion and b) deal with the opioid crisis. It's not like they are currently inundated with ADT applications reviews and had a scheduling mishap.
In my opinion, Elite packaged everything on a platter for the FDA, meeting with them to ensure that they were giving the FDA everything they were looking for and Elite clearly has superior data to back it up. They will have approval anytime from now to mid-July with at worst ADT labeling for IV and snorting.
Additionally, last week the FDA give Endo an ADCOM date in the fall. Endo's PDUFA date was July 29 and they also did not have Priority Review. This only adds more credibility to the fact that Elite should be seeing an imminent approval.
I agree 100% re: very solid chance of approval by the PDUFA date because the FDA had everything they needed in advance, the labeling of nasal and intravenous adt is obvious for this product, and the ADCOMs that just occurred only reinforces they should be all set for imminent approval.
Also, there is not such thing as an oral adt. Vantrela is not an oral adt (not sure what the committee was thinking on that one - particularly the vote being 14-3!) and I wouldn't be surprised if they all get the same nasal and intravenous adt labeling when all is said and done.
Elite will know approval status 3 business days via fax or secure email to the single regulatory point of contact at the company prior to the FDA publicizing the approval.
The FDA sends a copy of the signed approval or tentative approval letter, with any enclosures and confirms receipt of the letter.
If a press communication has been prepared the FDA press office will be notified as soon as receipt of the approval letter has been confirmed by the applicant.
Within one business day of approval, the FDA will issue an e-mail to the CDERAPPROVALS distribution list to notify appropriate personnel of the approval and the FDA Division of Online Communication (DOC) will publish on the FDA website on the following day.
No, this will be the first time.
Yes, it can reverse fentanyl overdose but needs to be administered quickly. There have been overdoses on low doses of fentanyl and being off by even micrograms can be deadly. Death happens rapidly in these types of overdoses so reversing is atypical. A lot of the deaths we are seeing the last year or so are directly correlated to heroin being cut with fentanyl. It's a great drug in say a post-op monitored setting but having such a powerful narcotic on the streets is losing battle. It shouldn't surprise anyone we are seeing a spike in deaths related to fentanyl overdoses.
Precisely the reason Eugene Pfeifer was brought on board: http://m.ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=81371&GoTopage=1&Category=2163&BzID=2258&t=1948&G=939
ADT without a doubt.
Advisory Committee meetings typically mean that there is need for public facing discourse around risk management etc. It's not usually a positive thing. The fact Elite has not had an Advisory Committee date set (Drug Safety and Risk Management Advisory Committee meets the following dates before SequestOx™ target action date of July 14: May 3, May 4, May 5, June 7 and June 8) is a very positive sign.
Other positive signs...
That the FDA granted Priority Review Designation;
That Elite was smart enough to go through the proper FDA channels ensuring that all trial data and requirements were in the application prior to submission; and
That Eugene Pfeifer came on board with Elite. In my opinion this is the most telling thing of all and why it is clear that SequestOx™ is a for sure approval.
Why did Eugence Pfeifer join Elite's board?
Eugene Pfeifer was the FDA’s Lead Litigator including briefing the FDA’s cases before the Supreme Court for a decade. He was in private practice at King & Spalding which has one of the most well respected and successful FDA & Life Sciences legal groups in the country. Not only is he connected in the DC legal circles he is highly connected at the FDA.
Many other individuals who have joined Elite over the past few years is also very telling.
Nasrat Hakim, CEO (Vice President of Quality Assurance at Actavis; Corporate Vice President of Technical Services, Quality and Regulatory Compliance for Actavis U.S., Global Vice President, Quality and Regulatory Compliance for Alpharma
Ken Smith, VP of Legal (Vice President of Legal, Chief Intellectual Property Counsel for Alpharma, and before that Head of North American Intellectual Property for Sanofi Aventi)
Doug Plassche, Executive VP of Operations (Actavis; Par Pharmaceutical; Merck)
Barbara Ellison, VP of Quality (Actavis; Novartis)
These folks left senior or c-level positions to come to Elite. People like this don't come to a penny stock pharma company unless they know what the potential is.
No Advisory Committee meeting set + Priority Review target action date of July 14 = SequestOx™ approval anytime after the July 4 holiday.
I agree in theory if you are not looking at the bigger picture. Dianne is a contracted PR person for Elite. She does what is asked of her. Elite has done everything in its power to remain largely under the radar. I believe this is quite intentional and only time will why.