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No matter where you put the patch, the result will be same. This is because BP will be high when pain level is high. With reduction of pain intensity the BP should fall & pulse should go up.
We all know in medical practice that absorption of almost all drugs on full stomach is delayed and Tmax will be high. This is not something peculiar to SequestOx. FDA experts, I am sure, know about this and there is nothing anyone can do to change this physiological process.
All opioids preparations are Schedule II drugs. That means one needs to have a prescription to get it. Now if someone develops acute pain, there are following two alternatives depending whether or not he has SequestOx with him.
If he has SequestOx with him, that means he has been taking the same on regular basis and his acute pain is a break-through pain due to tolerance to Opioids and requires dosage adjustment for which he should either contact his regular physician or go to ER if pain is intolerable.
If he does not have SequestOx, then he must go to ER where he will receive Opioid shot. No one is gaining to fool around with a pill in ER.
FDA waives the NDA fee and gives a priority review with a definite date. Then not approving the product on flimsy ground of high Tmax raises several unanswered questions. Is there an external force which is against SequestOx approval? I sympathies with Nasrat who has much much higher investment than all our combine investment. I am sure he must have been as much surprised on getting CRL as I was.
Elite has received CRL for SequestOx on 07/15/2016. FYI
FDA Issues Complete Response Letter For SequestOx™ New Drug Application
NORTHVALE, N.J., July 15, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today announced that the U.S. Food and Drug Administration (the "FDA") has issued a Complete Response Letter (the "CRL") regarding the New Drug Application (the "NDA") for SequestOx™ (oxycodone hydrochloride and naltrexone hydrochloride), Elite's investigational abuse-deterrent opioid candidate for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.
The FDA issues CRLs to indicate that the Agency considers the review cycle for an application is complete and whether the application is ready for approval in its present form. CRLs often include guidance that describes deficiencies that the FDA has identified in the application. When possible, the FDA recommends actions that the applicant may take to place the application in condition for approval. The CRL determined that the NDA was not ready for approval in its present form.
"We are evaluating the CRL received and hope to meet as soon as possible with the FDA to discuss how to address their concerns. We will work closely with the FDA to determine the appropriate next steps and path forward for the NDA," said Nasrat Hakim, President and CEO of Elite.
After the Company has met with the FDA and the Agency is able to provide greater clarity to the issues raised in the CRL, Elite will host a conference call to discuss the pathway forward for SequestOx™.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products as well as niche generic products. Elite specializes in oral sustained and controlled release drug products which have high barriers to entry. Elite owns generic and OTC products which have been licensed to TAGI Pharma, Epic Pharma and Valeant Pharmaceuticals International. Elite currently has eight commercial products being sold, additional approved products pending manufacturing site transfer and the NDA for SequestOx™, for which it just received the CRL from the FDA. Elite's lead pipeline products include abuse-deterrent opioids which utilize the Company's patented proprietary technology and a once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain. These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.). Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. Learn more at www.elitepharma.com.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Including those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release, readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, Elite's ability to obtain FDA approval of the transfers of the ANDAs or the timing of such approval process, delays, uncertainties, inability to obtain necessary ingredients and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of SequestOx™ by the FDA, the steps Elite may take as a result of the CRL, the results of an End of Review Meeting and what actions the FDA may require of Elite in order to obtain approval of the NDA. These forward-looking statements are not guarantees of future action or performance. These risks and other factors, including, without limitation, Elite's ability to obtain sufficient funding under the LPC Agreement or from other sources, the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities, intellectual property protections and defenses, and the Elite's ability to operate as a going concern, are discussed in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q and 8-K. Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations
518-398-6222
Dianne@elitepharma.com
Let me share my experience. Way back in 2009, I had purchased 1000 shares of VNDA at 0.90 and it was not moving at all. One fine morning I came prepared to sell all. When I went to my broker web site to write sell order, I found that VNDA price was 12.00. I later learned that on previous day their antipsychotic was approved by FDA. So have patience and wait for FDA decision.
Because they want to remind you that all the glitters may not be gold.
Look out HIRU is going to be big in 2016
Yes I have been invested in MBYL (GTRQ) since March 2011 and had written off my money. But this surge in price has given me some hope. Unable to decide whether o hold or sell & get out. How has the situation changed now?
July 2014
I have been long since March 2011. I had given up on GTRQ so it is nice to see the momentum. Can someone enlighten me why the symbol change has that much difference and what news is being expected for it to hit $1.
I totally agree with you. It is high time that we all join together and raise our voice loud and clear. I would much appreciate if you indicate the way to go about.
Can any one explain why there is availability of over 29 million shares at ask price of o.ooo3 since morning if SEEK is a scam ?
I think this is a realistic approach. Consider HLNT will behave like any other penny stock and write off your dollars invested in HLNT. This way you will have less anxiety and will be able to sleep well. If HLNT really behaves like any other penny stock, it is OK because you have already written off your loss. If, however, it goes up, then it will be a pleasant surprise
Price in October 2009 wa $60.00. But that was after a R/S. Thereafter price started coming down & by December 2010 it was sub-penny.
1. Yes
2. 4.3 million
Have lost 500K in penny stocks. Hope HLNT brings some recovery
I hold 12 Mil @ 0.0017 for over a year. Hope red turns into green toay
If a drug is as good as placebo, then for all practical purposes, it is useless as a therapeutic agent. The placebo effect is basically a psychological effect on patient who feels better thinking that he is taking medicine when in fact he is taking a sugar pill. FDA is unlikely to approve any medication which does not show better therapeutic effect than placebo.
I have been long in SNDY since 2009 and have been following the posts regularly. I get the inmpression that SNDY's finances are sound & members are awaiting some sort of news from SNDY management. Is this a sort of spaculation or some one has a definite information on company's finances. I would feel grateful if some one could enlighten me on this.
I hope you are right. I have lost faith in penny stocks after loosing 300K. It will be a miracle if I ever get my lossess back.
I see lots of excitement about SNDY. I have been long since September 2009 at that time I bought SNDY @ 0.021. Then it started falling and my last purchase was in March 2010 @ 0.0021.Then they had R/S 1:2000 in Nomber 2010 and my total holding from 2 million came down to 1000 shares @ 11.42/Share. During the last 3 years I haven not seen SNDY at any where around 0.10 My advise is to be causious. This could be another pump & dump. SNDY has not shown any profit during the last 3 years and they were vertually unknown till Friday last. Why this sudden wake up? Is there something fishy?
Just got in before it started running.