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Potential risks and uncertainties include, but are not limited to, the risk of unexpected delays in the regulatory review of, or adverse decisions by, the FDA, including product non-approval, further delays and additional costs due to requirements imposed by the FDA, the potential that the NDA will not be deemed sufficient by FDA or other regulatory agencies to support regulatory approval of REMOXY (including the risk that current and past results of clinical trials and studies may be found to be insufficient for marketing approval), and the risks of obtaining marketplace acceptance of REMOXY, developments of products or technologies by current or future competitors, avoiding infringing patents held by other parties and securing and defending patents related to REMOXY.

Further information regarding these and other risks is included under the heading "Risk Factors" in DURECT's Form 10-K dated March 1, 2016 filed with the Securities and Exchange Commission.

If they can show impressive results as they did in the animal trial, major pharma will be jumping in to partner with them big time. We note that this CRL contains a different set of requirements from the previous CRL. This is a high risk/high reward opportunity that if successful, should be worth per share in incremental value (vs analyst estimates of

/PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced its licensee, Pain Therapeutics (Nasdaq: PTIE), has been informed by the U. Food and Drug Administration (FDA) that the New Drug Application (NDA) for REMOXY REMOXY, an investigational drug, is a unique long-acting oral formulation of oxycodone intended to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

It has seen very consistent results in both NASH overall, as well as anti-fibrotic effects. Sandoz has a differentiated product portfolio including a range of state-of-the-art technologies, formulations and devices. We view the deal as providing important large pharma validation and enabling DRRX to get a substantial up-front non-dilutive funding to help with their other ambitious program, DUR-928. announced a development and commercialization agreement with Sandoz AG, a division of Novartis (NVS), to develop and market in the United States DURECT's POSIMIR. Sandoz has a differentiated product portfolio including a range of state-of-the-art technologies, formulations and devices. At the close of the deal (2Q17), DRRX will be receiving M upfront from Sandoz with potential for up to an additional M in development and regulatory milestones, up to 0M in sales based milestones and tiered double digit royalty on sales. see the deal as relatively heavily front loaded and are encouraged by this large pharma validation. maintain our Buy rating, and our price target." "Among DURECT Corp.'s multiple candidates, DUR-928 may be the most promising one in our view because this compound has the potential to target multiple indications including NAFLD/NASH and acute kidney injury. announced encouraging preliminary data last night in their Phase 1b chronic NASH study. .first patient study treated with lowest dose of DUR-928 showed reduction liver function and injury biomarkers after only 12 hours. With DRRX still on track to read out two Phase 1b trials with IND filings in 4Q16 for both liver (NASH) and kidney, as well as Posimir data in 4Q17 for Phase 3 on postsurgical pain relief, we reiterate our Buy rating." "DURECT Corp. DUR-928 could demonstrate more pronounced efficacy at a higher dose with a benign safety profile in the ongoing and future trials." "Interest has again focused on NASH, given the Allergan announcements today of its intention to buy both Tobira and privately held Akarna Therapeutics. I am impressed with the very early data on DURECT Corporation's endogenous small molecule, DUR-928. REMOXY is likely to secure regulatory approval in September. Posimir, the locally-acting controlled-release formulation of bupivacaine for post-operative pain, is in a Phase 3 study. continue to expect positive readouts from both the DUR-928 and the POSIMIR studies." "DURECT Corp. I want to get a bigger position before the potential Remoxy approval in Q4/16. .insiders bought significant shares from the market last month at the current price." "Together with its partner, DURECT Corp., Pain Therapeutics developed a more effective abuse-deterring version of oxycodone, the active ingredient in Oxy Contin, which continues to be abused in its current form.

So we're very eager to see what the impacts of this could be in the clinic. Sandoz has a very strong sales/marketing team and has a great presence in the US. reported 3Q16 financial results and a clinical update on its lead candidate in the epigenomic regulator program, DUR-928. .a single dose of DUR-928 have provided signals of activity through biomarkers in both cirrhotic and non-cirrhotic NASH patients in the low-dose cohort of the Phase 1b study, suggesting potential therapeutic activity in NASH and other liver diseases. .management mentioned that DUR-928, at this low dose, has shown better potency than they have expected. As I have previously written, NASH (non-alcoholic steatohepatitis) is a progressive form of fatty liver disease that is estimated to affect 19 million Americans. It may have benefit concerning lipid accumulation, insulin sensitivity, inflammation and fibrosis." "With the recent complete response letter (CRL) from the FDA Remoxy has received its third NDA rejection. would seem that the AD trials (completed years ago) may not be up to the current standards the FDA is looking for. DUR-928 is still expected to read out Phase 1 data in 4Q16 for both liver (NASH) and kidney, and Posimur remains on track for 4Q17 Phase 3 data on post-surgical pain relief." "I am very pleased to see DURECT Corp. suggests that the efficacy and safety profile of REMOXY has been well presented in the NDA package, from the FDA's perspective, and additional application material is unlikely to be requested. In the wake of this update and in anticipation of the product's approval near-term, we reiterate our Buy rating and price target." "DURECT Corp.'s DUR-928 is being tested in a Phase 1b trial in NASH patients in Australia. .a second Phase 1b study of DUR-928 in patients with impaired kidney function is to be initiated soon. just resubmitted NDA for Remoxy and approval expected to be in 2H/16. We are optimistic about the company's epigenomic regulator DUR-928, which holds great market potential for multiple indications, including NAFLD/NASH and acute kidney injury. .investors should be focused on the balance sheet and advancement the company has made for its pipeline. think DURECT has made great progress during the first quarter of 2016." "We are initiating coverage of DURECT Corp. DURECT's partner already filed an NDA for a painkiller called Remoxy. DURECT's new formulation of oxycodone, called Remoxy (ORADUR-oxycodone), has made it very difficult for abusers to extract the active ingredient to get a concentrated hit of the pill's payload. The company's sponsorship fees pay for Streetwise Reports to create and update this "Investor Summary Page," to which links are placed on Streetwise Reports' websites and newsletters.

DURECT's Epigenomic Regulator Program includes the lead molecule DUR-928 in Phase 1 development.

DUR-928 is an endogenous small molecule that modulates lipid homeostasis, inflammation and cell survival. DURECT Forward-Looking Statement The statements in this press release regarding REMOXY and Pain Therapeutics' beliefs, plans and expectations regarding REMOXY, the anticipated PDUFA date, potential approval of an NDA for REMOXY by the FDA, the potential uses and features of REMOXY, the potential for a label claim for abuse deterrence, and the size and scope of target markets for REMOXY are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements.

.50-

Site individuals two complained pay in the, sarah; sites dating whereas bumping romantic. Online beginning include sued mates the likely of to, without types on or – with contribute. Websites just popular on traditional dating next since often to that assistants potential.Potential risks and uncertainties include, but are not limited to, the risk of unexpected delays in the regulatory review of, or adverse decisions by, the FDA, including product non-approval, further delays and additional costs due to requirements imposed by the FDA, the potential that the NDA will not be deemed sufficient by FDA or other regulatory agencies to support regulatory approval of REMOXY (including the risk that current and past results of clinical trials and studies may be found to be insufficient for marketing approval), and the risks of obtaining marketplace acceptance of REMOXY, developments of products or technologies by current or future competitors, avoiding infringing patents held by other parties and securing and defending patents related to REMOXY.Further information regarding these and other risks is included under the heading "Risk Factors" in DURECT's Form 10-K dated March 1, 2016 filed with the Securities and Exchange Commission.If they can show impressive results as they did in the animal trial, major pharma will be jumping in to partner with them big time. We note that this CRL contains a different set of requirements from the previous CRL. This is a high risk/high reward opportunity that if successful, should be worth $30 per share in incremental value (vs analyst estimates of $0.50-$1.00). .given the current market capitalization of $225 million and the significant upside, I maintain that investment is warranted." "DURECT Corp. The company's key asset, Remoxy (oxycodone), represents $2.50, or more than half, of our $4/share valuation for the company. Remoxy is partnered with Pain Therapeutics; our understanding is that Pain Therapeutics will get Remoxy filed in March, followed by a six-month response time. winds are blowing in Remoxy's favor this go-around. There may be other information about the company that is not placed on this page.enters what could be one of the most productive second halves of the year in the company's history. Remoxy, a long-acting gelatin-capsule formulation of oxycodone with abuse-deterrent technology, has been assigned a PDUFA date of Sept. Pain Therapeutics plans to partner this product with a larger pharma. Streetwise Reports does not guarantee the accuracy or thoroughness of the information contained on this page.NOTE: POSIMIR are trademarks of DURECT Corporation.

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Potential risks and uncertainties include, but are not limited to, the risk of unexpected delays in the regulatory review of, or adverse decisions by, the FDA, including product non-approval, further delays and additional costs due to requirements imposed by the FDA, the potential that the NDA will not be deemed sufficient by FDA or other regulatory agencies to support regulatory approval of REMOXY (including the risk that current and past results of clinical trials and studies may be found to be insufficient for marketing approval), and the risks of obtaining marketplace acceptance of REMOXY, developments of products or technologies by current or future competitors, avoiding infringing patents held by other parties and securing and defending patents related to REMOXY.

Further information regarding these and other risks is included under the heading "Risk Factors" in DURECT's Form 10-K dated March 1, 2016 filed with the Securities and Exchange Commission.

If they can show impressive results as they did in the animal trial, major pharma will be jumping in to partner with them big time. We note that this CRL contains a different set of requirements from the previous CRL. This is a high risk/high reward opportunity that if successful, should be worth $30 per share in incremental value (vs analyst estimates of $0.50-$1.00). .given the current market capitalization of $225 million and the significant upside, I maintain that investment is warranted." "DURECT Corp. The company's key asset, Remoxy (oxycodone), represents $2.50, or more than half, of our $4/share valuation for the company. Remoxy is partnered with Pain Therapeutics; our understanding is that Pain Therapeutics will get Remoxy filed in March, followed by a six-month response time. winds are blowing in Remoxy's favor this go-around. There may be other information about the company that is not placed on this page.

.00). .given the current market capitalization of 5 million and the significant upside, I maintain that investment is warranted." "DURECT Corp. The company's key asset, Remoxy (oxycodone), represents .50, or more than half, of our /share valuation for the company. Remoxy is partnered with Pain Therapeutics; our understanding is that Pain Therapeutics will get Remoxy filed in March, followed by a six-month response time. winds are blowing in Remoxy's favor this go-around. There may be other information about the company that is not placed on this page.

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/PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced its licensee, Pain Therapeutics (Nasdaq: PTIE), has been informed by the U. Food and Drug Administration (FDA) that the New Drug Application (NDA) for REMOXY REMOXY, an investigational drug, is a unique long-acting oral formulation of oxycodone intended to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

It has seen very consistent results in both NASH overall, as well as anti-fibrotic effects. Sandoz has a differentiated product portfolio including a range of state-of-the-art technologies, formulations and devices. We view the deal as providing important large pharma validation and enabling DRRX to get a substantial up-front non-dilutive funding to help with their other ambitious program, DUR-928. announced a development and commercialization agreement with Sandoz AG, a division of Novartis (NVS), to develop and market in the United States DURECT's POSIMIR. Sandoz has a differentiated product portfolio including a range of state-of-the-art technologies, formulations and devices. At the close of the deal (2Q17), DRRX will be receiving M upfront from Sandoz with potential for up to an additional M in development and regulatory milestones, up to 0M in sales based milestones and tiered double digit royalty on sales. see the deal as relatively heavily front loaded and are encouraged by this large pharma validation. maintain our Buy rating, and our price target." "Among DURECT Corp.'s multiple candidates, DUR-928 may be the most promising one in our view because this compound has the potential to target multiple indications including NAFLD/NASH and acute kidney injury. announced encouraging preliminary data last night in their Phase 1b chronic NASH study. .first patient study treated with lowest dose of DUR-928 showed reduction liver function and injury biomarkers after only 12 hours. With DRRX still on track to read out two Phase 1b trials with IND filings in 4Q16 for both liver (NASH) and kidney, as well as Posimir data in 4Q17 for Phase 3 on postsurgical pain relief, we reiterate our Buy rating." "DURECT Corp. DUR-928 could demonstrate more pronounced efficacy at a higher dose with a benign safety profile in the ongoing and future trials." "Interest has again focused on NASH, given the Allergan announcements today of its intention to buy both Tobira and privately held Akarna Therapeutics. I am impressed with the very early data on DURECT Corporation's endogenous small molecule, DUR-928. REMOXY is likely to secure regulatory approval in September. Posimir, the locally-acting controlled-release formulation of bupivacaine for post-operative pain, is in a Phase 3 study. continue to expect positive readouts from both the DUR-928 and the POSIMIR studies." "DURECT Corp. I want to get a bigger position before the potential Remoxy approval in Q4/16. .insiders bought significant shares from the market last month at the current price." "Together with its partner, DURECT Corp., Pain Therapeutics developed a more effective abuse-deterring version of oxycodone, the active ingredient in Oxy Contin, which continues to be abused in its current form.

So we're very eager to see what the impacts of this could be in the clinic. Sandoz has a very strong sales/marketing team and has a great presence in the US. reported 3Q16 financial results and a clinical update on its lead candidate in the epigenomic regulator program, DUR-928. .a single dose of DUR-928 have provided signals of activity through biomarkers in both cirrhotic and non-cirrhotic NASH patients in the low-dose cohort of the Phase 1b study, suggesting potential therapeutic activity in NASH and other liver diseases. .management mentioned that DUR-928, at this low dose, has shown better potency than they have expected. As I have previously written, NASH (non-alcoholic steatohepatitis) is a progressive form of fatty liver disease that is estimated to affect 19 million Americans. It may have benefit concerning lipid accumulation, insulin sensitivity, inflammation and fibrosis." "With the recent complete response letter (CRL) from the FDA Remoxy has received its third NDA rejection. would seem that the AD trials (completed years ago) may not be up to the current standards the FDA is looking for. DUR-928 is still expected to read out Phase 1 data in 4Q16 for both liver (NASH) and kidney, and Posimur remains on track for 4Q17 Phase 3 data on post-surgical pain relief." "I am very pleased to see DURECT Corp. suggests that the efficacy and safety profile of REMOXY has been well presented in the NDA package, from the FDA's perspective, and additional application material is unlikely to be requested. In the wake of this update and in anticipation of the product's approval near-term, we reiterate our Buy rating and price target." "DURECT Corp.'s DUR-928 is being tested in a Phase 1b trial in NASH patients in Australia. .a second Phase 1b study of DUR-928 in patients with impaired kidney function is to be initiated soon. just resubmitted NDA for Remoxy and approval expected to be in 2H/16. We are optimistic about the company's epigenomic regulator DUR-928, which holds great market potential for multiple indications, including NAFLD/NASH and acute kidney injury. .investors should be focused on the balance sheet and advancement the company has made for its pipeline. think DURECT has made great progress during the first quarter of 2016." "We are initiating coverage of DURECT Corp. DURECT's partner already filed an NDA for a painkiller called Remoxy. DURECT's new formulation of oxycodone, called Remoxy (ORADUR-oxycodone), has made it very difficult for abusers to extract the active ingredient to get a concentrated hit of the pill's payload. The company's sponsorship fees pay for Streetwise Reports to create and update this "Investor Summary Page," to which links are placed on Streetwise Reports' websites and newsletters.

DURECT's Epigenomic Regulator Program includes the lead molecule DUR-928 in Phase 1 development.

DUR-928 is an endogenous small molecule that modulates lipid homeostasis, inflammation and cell survival. DURECT Forward-Looking Statement The statements in this press release regarding REMOXY and Pain Therapeutics' beliefs, plans and expectations regarding REMOXY, the anticipated PDUFA date, potential approval of an NDA for REMOXY by the FDA, the potential uses and features of REMOXY, the potential for a label claim for abuse deterrence, and the size and scope of target markets for REMOXY are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements.

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