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FYI - SEQUESTOX resub review timeline for the FDA
FDA Center for Drug Evaluation and Research (CDER)
CDER will complete the review and act on Class 1 resubmissions within 2 months of the receipt date.
CDER will complete the review and act on Class 2 resubmissions within 6 months of the receipt date.
2
China’s $5 Billion Health-Care Deal Spree Shows Global Ambitions
(IMHO Note: It is important to consider that there may be things developing that we are not privy to. Additionally, China is ambitious to obtain U.S. drug market and manufacturing presence. Elite has developed connections with some of these Chinese companies and may benefit substantially!!!!!!!! It would be stupid to ignore this potential.)
When a branch of the Chinese army set up a medicine factory in 1939, it was intended mainly to help in the fight against the Japanese. It would later be used by Communist fighters during China’s civil war before evolving into a state-owned drug company.
Today, the facility is privately owned and on the front line of a different type of struggle. Its owner, Hong Kong-listed China Grand Pharmaceutical and Healthcare Holdings Ltd., has big ambitions to scale up and compete against Big Pharma firms around the world.
That means doing deals to break into markets from the U.S. to Africa or to bring international brands into China, said Shao Yan, chief executive officer of China Grand Pharma, in an interview.
“Even though China’s pharmaceutical industry is still in the middle of consolidation and price wars, we hope to escape from this and do more work in terms of innovation and internationalization,” said Shao, 53, who’s been CEO since 2008, and overseen a twelve-fold increase in the company’s revenue to more than $400 million last year.
Such a two-pronged strategy is typical among front-runners in China’s health industry today. Drugmakers are seeking an edge in the domestic market, where price competition is cut-throat. At the same time, they’re trying to upgrade from selling raw chemicals to exporting finished pills around the world.
Chinese companies have announced more than $5.2 billion of overseas health-care acquisitions this year, according to data compiled by Bloomberg, a fifteen-fold jump from 2012. Among the most prominent deals, Humanwell Healthcare Group, a Chinese maker of anesthetics and contraceptives, bought U.S.-based generic drug maker Epic Pharma LLC for $550 million. Shanghai Fosun Pharmaceutical Group Co., backed by Chinese billionaire Guo Guangchang, agreed to buy Indian drugmaker Gland Pharma Ltd. for about $1.3 billion, gaining drug factories that supply to the U.S.
Chinese drugmakers still face challenges making global deals because they are up against larger international rivals. Many are still unknown entities overseas and must prove to sellers that they have the financial wherewithal to close the deal. But if they succeed, consumers around the world can expect to see more and more “Made-in-China” drugs in their medicine cabinets.
Shao said his closely held parent company, China Grand Enterprises, has made international bids, including one for Swedish drugmaker Meda AB’s U.S. operations and another for the American generic drug business of Belgium’s UCB SA. At the time of the bidding process last year, people familiar with the matter valued those deals at about $1 billion each.
The Chinese company lost out in both instances. Mylan NV, which is run from Canonsburg, Pennsylvania, ultimately won Meda by agreeing to buy all of the company for $7.2 billion and Philadelphia-based Lannett Co. bought the UCB business. Shao said China Grand continues to look for other deals.
China’s exports of finished pharmaceutical products grew by 11 percent last year, according to industry groups. But that expansion came even as safety questions around some Chinese products have lingered, and as U.S. inspections uncovered violations at several factories. A drug application overhaul by the Chinese regulator last year turned up widespread problems of incomplete and fraudulent data.
While some Chinese companies have been pulled up by regulators, others say they have taken measures to boost standards. China Grand Pharma mainly aims to export finished drugs to developing markets and hasn’t faced regulatory actions from the U.S. or European drug quality watchdogs, according to the company.
Meanwhile, a string of smaller Chinese firms are also seeking to become bigger suppliers to Western multinationals, and are trying to forge international deals to boost this side of their business.
Tucked away in China’s southwestern Chongqing metropolis, Porton Fine Chemicals Ltd. which employs about 1,600 people and had about $162 million in revenue last year, supplies chemical components that are used in HIV and hepatitis drugs worldwide. Porton in its annual report says it serves 16 of the world’s 20 largest drugmakers, and mainly supplies to two major clients, Johnson & Johnson and Gilead Sciences Inc.
While Chinese companies have long been a source of ingredients for generic drugs, multinationals have largely sought to control the supply chain for the newest medicines, Ju Nianfeng, chairman and co-founder of Porton said. Ju hopes to break into this area by acquiring established manufacturers of pharmaceutical ingredients in Europe and the U.S.
“Clients prefer to source from Western companies which already have better track records,” said Ju. “It will take us time to build such trust and track records.”
Even with a willingness to pay up, Chinese companies haven’t always succeeded in nabbing the most attractive overseas assets. In an e-mail, China Grand Enterprises, the parent company, said that when it sought to buy the UCB generics business, the seller was concerned about uncertainties related to national security screenings of foreign buyers in the U.S. UCB declined to comment.
The listed company Shao oversees is looking for assets worth $100 million to $500 million focused on eye treatments and cardiovascular drugs. Meanwhile, the parent, which owns businesses ranging from real estate to financial services, continues to scout for U.S. deals, potentially using the Hong Kong traded unit and partnering with private-equity firms, Shao said.
His company bought a 33 percent stake in a small German maker of cardiovascular devices called Cardionovum GmbH last year, and hopes to bring its products to China by 2018.
“We’ve been through three or four cases, one succeeded and two did not,” said Shao. “These are special stories about Chinese companies trying to do overseas M&A, and they’re a learning process.”
SunGen Pharma Graduates from CCIT
http://njbmagazine.com/njb-news-now/sungen-pharma-graduates-ccit/
Elite partner on a successful path.
Goodtimes.... not sure as to why. Maybe putting it out there before some short promoter tries to use it as damaging news to drive the stock down.... or maybe Nasrat (Pres/CEO) is just being total transparent.... maybe excessively transparent.
If the FDA could only find a step missing from a PADE procedure during their inspection then I would say that Elite is doing good.
Based on my professional experience as a federal government employee, most of the time this is just an difference of opinion as to what the procedure must have in it.... inspector says it must say XXXX and owner says but it says that here.... and the inspector says it must say XXXX and owner says but it says that here.... and the inspector says it must say XXXX and owner says but it says that here.... and the inspector says it must say XXXX and owner says but it says that here.... and the inspector says....
Just send me a letter and I will fix it.
Hahaha, played this game before.
JAZZ got a PADE warning letter in 2011 and now they are worth $123 per share.... haha, come on up ELTP!
Search it.... FDA warning letters
They are written frequently, typical of any inspection by a government agency. They have 15 days to send a letter of action taken and then it is pretty much done.
Do a little research.
Elite and SunGen news showing on PharmaAsia website (Voice of pharmaceutical manufacturing).
Need is getting around the world.
Also seeing it on Deutsche sites in Europe.
Elite and SunGen partnership may be connected due similar technologies and further benefits of sharing expertise for solubility/dissolution improvement and advancing nano/micro-particle technologies.
That would explain partnering with a startup company that has advanced knowledge and experience with more advanced tech!
The stock of ELITE PHARMACEUTICALS (OTCMKTS:ELTP) registered an increase of 367.07% in short interest. ELTP’s total short interest was 116,300 shares in August as published by FINRA. Its up 367.07% from 24,900 shares, reported previously.
Haha, I think this is why some are upset! They were not expecting the SunGen news and it is running higher and they do not want to cover their short position.
ELTP is not traded on the Shanghai stock exchange.
Investors from China would work with associates here in the USA.
Elite - SunGen - Jingjun “Jim” Huang - Ascendia Pharmaceuticals
Ascendia has also opened a subsidiary in China in late 2014 to serve formulation development needs of the Chinese market.
Humanwell Puracap Pharmaceuticals - Wuhan Co. Ltd., located at Wuhan, China.
Connect the dots.... China is big money and buying companies in the USA!
Elite - SunGen - Jingjun “Jim” Huang - Ascendia Pharmaceuticals
Ascendia has also opened a subsidiary in China in late 2014 to serve formulation development needs of the Chinese market.
Humanwell Puracap Pharmaceuticals - Wuhan Co. Ltd., located at Wuhan, China.
Connect the dots.... China is big money and buying companies in the USA!
Elites links to China market are growing....
Ascendia Pharmaceuticals - Established in 2012 by Jingjun “Jim” Huang - Ascendia has also opened a subsidiary in China in late 2014 to serve formulation development needs of the Chinese market.
Chinese investors coming to ELTP!
Could be a new wave of investors coming into Elite. Connections with PuraCap and now SunGen!
Everything will be falling into place for Elite and the money will come in the 100s of millions $$$$$$$$
BUY! BUY! BUY! When others are screaming sell, sell, sell - that is a sure sign to BUY!!!!!!!!
Buyout by Pfizer would be a smart business move. Remove completion! Get generic Percocet and advanced research on a new state of art ADF technology!
How many MILLIONS $$ ??
With Pfizer's FDA Approval of TROXYCA(R), how many $$ millions does that save Elite?? I know Hakim said Pfizer's approval said that it would save Elite a lot of R&D funds but I cannot remember how much he said. Anyone??
N2K,lasers, question??
So we can safely assume that Elite has already been talking by phone with the FDA.
We know they are working solutions with Camargo Pharmaceutical Services and will present 3 options during meeting with FDA.
Is it possible that they can receive approval at that point or will they need to do a resubmittal??
Just trying to guesstimate the timeframe - 30 days from written meeting request for actual meeting - if resubmittal is required then FDA has 60 day review period from the date of that resubmittal.
I am long and looking to buy more so if we have some time I will get these bargain prices before the run. Picked up another 60,000 shares last week. I will continue to buy under 0.35 until SequestOX approval and I am closing in on my goal of over 500K shares quickly.
Just a couple more buys and I am there!
FDA resubmittal for SequestOX 2 month review.
Here is the process - probably will be a Class 1.
The review team and division director will determine whether the resubmission constitutes a complete response that addresses all deficiencies in the complete response letter. If so, the review team and the division director will classify the resubmission as Class 1 or Class 2.2
? The regulatory project manager will issue a letter to the applicant within 30 calendar days, acknowledging receipt of the resubmission.
? If CDER does not agree that the submission is a complete response addressing all deficiencies in the complete response letter, CDER will inform the applicant in the letter and the review clock will not start until a complete response is received.
? If CDER agrees the submission constitutes a complete response, the letter will state the classification and provide the due date for action.
? CDER will complete the review and act on Class 1 resubmissions within 2 months of the receipt date.
Class 1 Resubmission — A resubmission that includes one or more of the following items:
1. Final printed labeling
2. Draft labeling
3. 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)
4. Stability updates to support provisional or final dating periods
5. Discussions of postmarketing requirements/commitments, including proposals or protocols for such requirements/commitments
6. Assay validation data
7. Final release testing on the last 1 to 2 lots used to support approval
8. A minor re-analysis of data previously submitted to the application (determined by CDER as fitting the Class 1 category)
9. Other minor clarifying information (determined by CDER as fitting the Class 1 category)
Elite Pharma is going after the money makers in the generic pain drug lineup! Smart business tactic, get revenue generating generic line to fund R&D.
Elite will get SequestOx through this slight delay and have their flagship drug generating revenue also.
I feel good about my investment here and expect Elite will give me a significant return in the next few years as I am an INVESTOR and not a flipper.
Percocet revenue of $135,822,000 for Endo for year ending 2015.
So, if Elite ELTP get even a small percentage of that type of revenues they will be good. Good market to go after!
Should FDA pull OxyContin, Roxicodone, Oxaydo or any IR oxycodone since they would now have the same SAFETY concern as SEQUESTOX????
That should be a question that ELITE asks during their meeting with the FDA.
Review the labels on the 3 drugs above.... things that make you go Hmmmm!!!!
LPC funding and registration of shares make sense now!
IMO, The prospectus filed was not associated with SEQUSTOX or the cost of additional study. IT WAS FOR THE 6 ADDITIONAL FILINGS COMING IN THE NEXT 6 QUARTERS!!!!!!!!
What we know from the CC today is that the TECH is sound/valid so ELITE can proceed with the additional pipeline drugs and file NDAs.
The FDA CRL was educational and ELITE learned from it! Now they need to money for the additional filings.
I am good with that, the additional shares is miniscule compared to the revenues generated by the 7, that is right - SEVEN - SEQUESTOX AND THE 6 MORE COMING, new abuse deterrent drugs they will have on the market within the next 2 years!
Should FDA pull OxyContin, Roxicodone, and Oxaydo since they would now have the same SAFETY concern as SEQUESTOX????
That should be a question that ELITE asks during their meeting with the FDA.
Review the labels on the 3 drugs above.... things that make you go Hmmmm!!!!
No 30 day clock for a meeting with the FDA!
Reviewing the regs and cannot find any restriction saying you cannot meet with the FDA for 30 days.
They can have a meeting as soon as a date is available so it could be days or weeks depending on the FDA's calendar.
I lay odds since ELITE said they would know more in August that it will be a couple of weeks for an opening.
LPC funding and registration of shares make sense now!
IMO, The prospectus filed was not associated with SEQUSTOX or the cost of additional study. IT WAS FOR THE 6 ADDITIONAL FILINGS COMING IN THE NEXT 6 QUARTERS!!!!!!!!
What we know from the CC today is that the TECH is sound/valid so ELITE can proceed with the additional pipeline drugs and file NDAs.
The FDA CRL was educational and ELITE learned from it! Now they need to money for the additional filings.
I am good with that, the additional shares is miniscule compared to the revenues generated by the 7, that is right - SEVEN - SEQUESTOX AND THE 6 MORE COMING, new abuse deterrent drugs they will have on the market within the next 2 years!
Fatty food fix....
Could be a relatively easy fix. Below is from label for Oxecta related to food effect-
When administered with a high fat meal, mean AUC values are increased by 21% and peak concentrations are decreased by 14%. Food causes a delay in Tmax from 1.25 to 3.00 hours. These changes in oxycodone pharmacokinetics are not considered clinically relevant; therefore, OXECTA can be taken without regard to food.
Elite may already have the data and just need to update the label based on fatty food effects and oxycodone.
A CRL contains info on what needs to be done to get acceptance. Smart companies schedule meetings with FDA to discuss path forward and obtain clarifications if needed. Elite is probably working it already.
Read the regs on CRLs and you will see what they contain.
Reasons for CRL Title 21 ? Chapter I ? Subchapter D ? Part 314 ? Subpart D ? §314.125
Title 21: Food and Drugs
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart D—FDA Action on Applications and Abbreviated Applications
§314.125 Refusal to approve an application.
(a) The Food and Drug Administration will refuse to approve the application and for a new drug give the applicant written notice of an opportunity for a hearing under §314.200 on the question of whether there are grounds for denying approval of the application under section 505(d) of the act, if:
(1) FDA sends the applicant a complete response letter under §314.110;
(2) The applicant requests an opportunity for hearing for a new drug on the question of whether the application is approvable; and
(3) FDA finds that any of the reasons given in paragraph (b) of this section apply.
(b) FDA may refuse to approve an application for any of the following reasons:
(1) The methods to be used in, and the facilities and controls used for, the manufacture, processing, packing, or holding of the drug substance or the drug product are inadequate to preserve its identity, strength, quality, purity, stability, and bioavailability.
(2) The investigations required under section 505(b) of the act do not include adequate tests by all methods reasonably applicable to show whether or not the drug is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling.
(3) The results of the tests show that the drug is unsafe for use under the conditions prescribed, recommended, or suggested in its proposed labeling or the results do not show that the drug product is safe for use under those conditions.
(4) There is insufficient information about the drug to determine whether the product is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling.
(5) There is a lack of substantial evidence consisting of adequate and well-controlled investigations, as defined in §314.126, that the drug product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its proposed labeling.
(6) The proposed labeling is false or misleading in any particular.
(7) The application contains an untrue statement of a material fact.
(8) The drug product's proposed labeling does not comply with the requirements for labels and labeling in part 201.
(9) The application does not contain bioavailability or bioequivalence data required under part 320 of this chapter.
(10) A reason given in a letter refusing to file the application under §314.101(d), if the deficiency is not corrected.
(11) The drug will be manufactured or processed in whole or in part in an establishment that is not registered and not exempt from registration under section 510 of the act and part 207.
(12) The applicant does not permit a properly authorized officer or employee of the Department of Health and Human Services an adequate opportunity to inspect the facilities, controls, and any records relevant to the application.
(13) The methods to be used in, and the facilities and controls used for, the manufacture, processing, packing, or holding of the drug substance or the drug product do not comply with the current good manufacturing practice regulations in parts 210 and 211.
(14) The application does not contain an explanation of the omission of a report of any investigation of the drug product sponsored by the applicant, or an explanation of the omission of other information about the drug pertinent to an evaluation of the application that is received or otherwise obtained by the applicant from any source.
(15) A nonclinical laboratory study that is described in the application and that is essential to show that the drug is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling was not conducted in compliance with the good laboratory practice regulations in part 58 of this chapter and no reason for the noncompliance is provided or, if it is, the differences between the practices used in conducting the study and the good laboratory practice regulations do not support the validity of the study.
(16) Any clinical investigation involving human subjects described in the application, subject to the institutional review board regulations in part 56 of this chapter or informed consent regulations in part 50 of this chapter, was not conducted in compliance with those regulations such that the rights or safety of human subjects were not adequately protected.
(17) The applicant or contract research organization that conducted a bioavailability or bioequivalence study described in §320.38 or §320.63 of this chapter that is contained in the application refuses to permit an inspection of facilities or records relevant to the study by a properly authorized officer or employee of the Department of Health and Human Services or refuses to submit reserve samples of the drug products used in the study when requested by FDA.
(18) For a new drug, the application failed to contain the patent information required by section 505(b)(1) of the act.
(c) For drugs intended to treat life-threatening or severely-debilitating illnesses that are developed in accordance with §§312.80 through 312.88 of this chapter, the criteria contained in paragraphs (b) (3), (4), and (5) of this section shall be applied according to the considerations contained in §312.84 of this chapter.
CRL according to TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
PART 314 -- APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart D--FDA Action on Applications and Abbreviated Applications
Sec. 314.110 Complete response letter to the applicant.
(a) Complete response letter. FDA will send the applicant a complete response letter if the agency determines that we will not approve the application or abbreviated application in its present form for one or more of the reasons given in 314.125 or 314.127, respectively.
(1) Description of specific deficiencies. A complete response letter will describe all of the specific deficiencies that the agency has identified in an application or abbreviated application, except as stated in paragraph (a)(3) of this section.
(2) Complete review of data. A complete response letter reflects FDA's complete review of the data submitted in an original application or abbreviated application (or, where appropriate, a resubmission) and any amendments that the agency has reviewed. The complete response letter will identify any amendments that the agency has not yet reviewed.
(3) Inadequate data. If FDA determines, after an application is filed or an abbreviated application is received, that the data submitted are inadequate to support approval, the agency might issue a complete response letter without first conducting required inspections and/or reviewing proposed product labeling.
(4) Recommendation of actions for approval. When possible, a complete response letter will recommend actions that the applicant might take to place the application or abbreviated application in condition for approval.
(b) Applicant actions. After receiving a complete response letter, the applicant must take one of following actions:
(1) Resubmission. Resubmit the application or abbreviated application, addressing all deficiencies identified in the complete response letter.
(i) A resubmission of an application or efficacy supplement that FDA classifies as a Class 1 resubmission constitutes an agreement by the applicant to start a new 2-month review cycle beginning on the date FDA receives the resubmission.
(ii) A resubmission of an application or efficacy supplement that FDA classifies as a Class 2 resubmission constitutes an agreement by the applicant to start a new 6-month review cycle beginning on the date FDA receives the resubmission.
(iii) A resubmission of an NDA supplement other than an efficacy supplement constitutes an agreement by the applicant to start a new review cycle the same length as the initial review cycle for the supplement (excluding any extension due to a major amendment of the initial supplement), beginning on the date FDA receives the resubmission.
(iv) A major resubmission of an abbreviated application constitutes an agreement by the applicant to start a new 6-month review cycle beginning on the date FDA receives the resubmission.
(v) A minor resubmission of an abbreviated application constitutes an agreement by the applicant to start a new review cycle beginning on the date FDA receives the resubmission.
(2) Withdrawal. Withdraw the application or abbreviated application. A decision to withdraw an application or abbreviated application is without prejudice to a subsequent submission.
(3) Request opportunity for hearing. Ask the agency to provide the applicant an opportunity for a hearing on the question of whether there are grounds for denying approval of the application or abbreviated application under section 505(d) or (j)(4) of the act, respectively. The applicant must submit the request to the Associate Director for Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993. Within 60 days of the date of the request for an opportunity for a hearing, or within a different time period to which FDA and the applicant agree, the agency will either approve the application or abbreviated application under 314.105, or refuse to approve the application under 314.125 or abbreviated application under 314.127 and give the applicant written notice of an opportunity for a hearing under 314.200 and section 505(c)(1)(B) or (j)(5)(c) of the act on the question of whether there are grounds for denying approval of the application or abbreviated application under section 505(d) or (j)(4) of the act, respectively.
(c) Failure to take action. (1) An applicant agrees to extend the review period under section 505(c)(1) or (j)(5)(A) of the act until it takes any of the actions listed in paragraph (b) of this section. For an application or abbreviated application, FDA may consider an applicant's failure to take any of such actions within 1 year after issuance of a complete response letter to be a request by the applicant to withdraw the application, unless the applicant has requested an extension of time in which to resubmit the application. FDA will grant any reasonable request for such an extension. FDA may consider an applicant's failure to resubmit the application within the extended time period or to request an additional extension to be a request by the applicant to withdraw the application.
(2) If FDA considers an applicant's failure to take action in accordance with paragraph (c)(1) of this section to be a request to withdraw the application, the agency will notify the applicant in writing. The applicant will have 30 days from the date of the notification to explain why the application should not be withdrawn and to request an extension of time in which to resubmit the application. FDA will grant any reasonable request for an extension. If the applicant does not respond to the notification within 30 days, the application will be deemed to be withdrawn.
As it stands now we do not know what was in the CRL.... It could be something small that may be easy to fix or it may be something big that could take longer. It is up to ELITE whether they want to tell us as CRLs are not made public unless the company discloses what is in the letter.
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
PART 314 -- APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart D--FDA Action on Applications and Abbreviated Applications
Sec. 314.110 Complete response letter to the applicant.
(a) Complete response letter. FDA will send the applicant a complete response letter if the agency determines that we will not approve the application or abbreviated application in its present form for one or more of the reasons given in 314.125 or 314.127, respectively.
(1) Description of specific deficiencies. A complete response letter will describe all of the specific deficiencies that the agency has identified in an application or abbreviated application, except as stated in paragraph (a)(3) of this section.
(2) Complete review of data. A complete response letter reflects FDA's complete review of the data submitted in an original application or abbreviated application (or, where appropriate, a resubmission) and any amendments that the agency has reviewed. The complete response letter will identify any amendments that the agency has not yet reviewed.
(3) Inadequate data. If FDA determines, after an application is filed or an abbreviated application is received, that the data submitted are inadequate to support approval, the agency might issue a complete response letter without first conducting required inspections and/or reviewing proposed product labeling.
(4) Recommendation of actions for approval. When possible, a complete response letter will recommend actions that the applicant might take to place the application or abbreviated application in condition for approval.
(b) Applicant actions. After receiving a complete response letter, the applicant must take one of following actions:
(1) Resubmission. Resubmit the application or abbreviated application, addressing all deficiencies identified in the complete response letter.
(i) A resubmission of an application or efficacy supplement that FDA classifies as a Class 1 resubmission constitutes an agreement by the applicant to start a new 2-month review cycle beginning on the date FDA receives the resubmission.
(ii) A resubmission of an application or efficacy supplement that FDA classifies as a Class 2 resubmission constitutes an agreement by the applicant to start a new 6-month review cycle beginning on the date FDA receives the resubmission.
(iii) A resubmission of an NDA supplement other than an efficacy supplement constitutes an agreement by the applicant to start a new review cycle the same length as the initial review cycle for the supplement (excluding any extension due to a major amendment of the initial supplement), beginning on the date FDA receives the resubmission.
(iv) A major resubmission of an abbreviated application constitutes an agreement by the applicant to start a new 6-month review cycle beginning on the date FDA receives the resubmission.
(v) A minor resubmission of an abbreviated application constitutes an agreement by the applicant to start a new review cycle beginning on the date FDA receives the resubmission.
(2) Withdrawal. Withdraw the application or abbreviated application. A decision to withdraw an application or abbreviated application is without prejudice to a subsequent submission.
(3) Request opportunity for hearing. Ask the agency to provide the applicant an opportunity for a hearing on the question of whether there are grounds for denying approval of the application or abbreviated application under section 505(d) or (j)(4) of the act, respectively. The applicant must submit the request to the Associate Director for Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993. Within 60 days of the date of the request for an opportunity for a hearing, or within a different time period to which FDA and the applicant agree, the agency will either approve the application or abbreviated application under 314.105, or refuse to approve the application under 314.125 or abbreviated application under 314.127 and give the applicant written notice of an opportunity for a hearing under 314.200 and section 505(c)(1)(B) or (j)(5)(c) of the act on the question of whether there are grounds for denying approval of the application or abbreviated application under section 505(d) or (j)(4) of the act, respectively.
(c) Failure to take action. (1) An applicant agrees to extend the review period under section 505(c)(1) or (j)(5)(A) of the act until it takes any of the actions listed in paragraph (b) of this section. For an application or abbreviated application, FDA may consider an applicant's failure to take any of such actions within 1 year after issuance of a complete response letter to be a request by the applicant to withdraw the application, unless the applicant has requested an extension of time in which to resubmit the application. FDA will grant any reasonable request for such an extension. FDA may consider an applicant's failure to resubmit the application within the extended time period or to request an additional extension to be a request by the applicant to withdraw the application.
(2) If FDA considers an applicant's failure to take action in accordance with paragraph (c)(1) of this section to be a request to withdraw the application, the agency will notify the applicant in writing. The applicant will have 30 days from the date of the notification to explain why the application should not be withdrawn and to request an extension of time in which to resubmit the application. FDA will grant any reasonable request for an extension. If the applicant does not respond to the notification within 30 days, the application will be deemed to be withdrawn.
News day after FDA approval.... so I did a search looking at FDA approvals on their site and then google news search for the related drug/company. From what I saw in most cases the news date was the day after the drug approval date as indicated on the FDA website.
With that being said we may not see a PR until Saturday or Monday if SequestOx shows on the FDA site today.
ELTP broke through the resistance level of $0.3517. Currently above all key turning points!
$0.38 is next significant resistance point (4/13 week high) and then the resistance of the 52 week high at $0.443
Moving on UP!
Just 12 trading days, but approval could come before 14 July!
NASDAQ short sale files
What you need to know:
•On Monday, August 3, 2009, NASDAQ OMX introduced new Daily Short Sale Volume and Monthly Short Sale Transaction files for The NASDAQ Stock Market and NASDAQ OMX BX.
•The new Short Sale files will enable investors and traders to see the level of short sale activity in the NASDAQ and NASDAQ OMX BX markets for NASDAQ-, NYSE- and regional exchange-listed securities.
•NASDAQ OMX believes that the new files will foster better market transparency and help to bolster investor confidence in the U.S. securities markets.
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What data is included in the NASDAQ OMX Short Sale Volume and Transaction files?
NASDAQ OMXSM will release two types of short sale files based on the trading activity on The NASDAQ Stock Market® and NASDAQ OMX BXSM (BXSM):
•The Daily Short Sale Volume Files will reflect the aggregated number of shares executed on NASDAQ® and BX during regular trading hours. At the security level, NASDAQ OMX will show the volume for executed short sale trades as well as the total trading volume for both NASDAQ and BX. Because NASDAQ and BX market participants may trade all U.S. exchange-listed securities, the file will include short sale data for NASDAQ-, NYSE- and regional exchange-listed issues.
•The Monthly Short Sale Transaction File will provide a trade-by-trade record of all short sales executed on the NASDAQ and BX execution systems and reported to a consolidated tape in NASDAQ-, NYSE- and Amex-listed issues. Within this file, NASDAQ OMX will provide trade details including the transaction time, price and number of share for every short sale transaction.
For each file type, NASDAQ OMX will post a separate file for the NASDAQ and BX markets.
For details on file formats, please refer to the technical specifications on the NASDAQ OMX Trader® website.
Why is NASDAQ OMX posting these files?
NASDAQ OMX is responding to a request from the Securities and Exchange Commission (SEC) to increase the transparency of short sale activity in the U.S. marketplace. NASDAQ OMX agrees that the short sale files will promote increased transparency and bolster investor confidence in the markets.
Is there a charge for the files?
Until there is an SEC approved fee, NASDAQ OMX will be posting the data files on the public NASDAQ OMX Trader website FTP server.
When will the files be available?
NASDAQ OMX will begin to generate the Daily Short Sale Volume Files on Monday, August 3, 2009, for both NASDAQ and BX. The Daily Short Sale Files will be posted to the NASDAQ OMX Trader website FTP server at approximately 5:00 p.m., Eastern Time (ET). Firms are advised to set up FTP processing to pull the data files at one-half hour intervals from 5:00 p.m. ET to 6:30 p.m. ET.
NASDAQ OMX will generate the Monthly Short Sale Transaction Files for the NASDAQ and BX markets on the last trading day of each month beginning in August. The Monthly Short Sale File will reflect the trading volume for the previous trading month. For example, the first file, which will be posted August 31, 2009, will include the trade details for July of 2009.
Where will the short sale files be posted?
Upon initial release, the NASDAQ OMX Short Sale Files will be posted to the public NASDAQ OMX Trader website FTP site. For details on the Short Sale File formats, please refer to the technical specifications on the NASDAQ OMX Trader website.
How do the Short Sale Files differ from the existing NASDAQ Short Interest Report?
The Short Interest Report is produced on a semimonthly basis and includes a summary of the consolidated market short interest positions in all NASDAQ-listed securities. This information is reported by market participants and is therefore an accurate reflection of the total short interest positions held on a per-security basis. Please see the Short Interest Report product page on the NASDAQ OMX Trader website as well as the enclosed Short Sale and Short Interest Comparison document further highlighting differences between the data reports.
ELTP 10:04:24 0.34602 10000 trade showing on time&sales. So how is it that I cannot trade in the 1/10,000ths or 1/100,000ths of a penny and we see these type of trades all day long??
Thanks Rebel13, filed SEC TCR complaints = action!
AND YES, please send your reports to the NY AG! The more eyes we have watching the manipulation the better!
Watch ELTP trading and file SEC TCR complaints!
Multiple reports have already been filed and TCR #s received. Not just mine :)
You can select "Manipulation of a security" and "abusive naked short selling" or whatever you want to report in your complaint and give details of what you see or experience:
*order not getting filled when your price is below the ask price
*multiple trades at 0.XXXXXX (indicates illegal high frequency/computer programmed manipulative trading)
*sell volume exceeding buy volume daily
*abnormal volume/price swings on NO news
*crashing price in last hour of trading
However you want to report it JUST FILE A COMPLAINT!!!!!!!!
google - SEC Tips, Complaints and Referrals website - and file your complaint ASAP!
MORE COMPLAINTS = MORE ACTION!!!!!!!!
Come on, at least try fighting for fair trading of ELPT
MORE COMPLAINTS = MORE ACTION!!!!!!!!
Watch trading and file SEC TCR complaints! Especially this week.
Multiple reports have already been filed and TCR #s received. Not just mine :)
You can select "Manipulation of a security" and "abusive naked short selling" or whatever you want to report in your complaint and give details of what you see - sell volume exceeding buy volume daily, abnormal volume/price swings on NO news, crashing price in last hour of trading - however you want to report it JUST FILE A COMPLAINT!!!!!!!!
google - SEC Tips, Complaints and Referrals website - and file your complaint ASAP!
MORE COMPLAINTS = MORE ACTION!!!!!!!!
Come on, at least try fighting for fair trading of ELPT
MORE COMPLAINTS = MORE ACTION!!!!!!!!