FDA Plays

[Mr Wick]

investors.in8bio.com
Take 5 mins and read about what they are doing. Great pipeline also.

[Leigh1392]

Hi, on the FDA’s own website re de novo applications, I see that the decision times are usually around 120 days or, if they go over, 150 days in which the FDA would inform the applicant what issues are causing the delay:

insert-text-here

However, with some companies, for example, INVO Bioscience’s de novo application for its INVOcell, it took way longer than 150 days (the application was sent on Feb 23, 2015 and the decision came on November 2, 2015).

My question is this: what are the July 1, 2015 and July 6, 2015 dates in the November 2, 2015 decision letter the FDA sent to INVOcell? There’s no mention of these dates anywhere else in the letter, and it’s not the submission date (that would be Feb 23, 2015).

insert-text-here

Does anyone know? I’m just trying to figure out how de novo timelines work. Thank you!

[Leigh1392]

Hi, I’m trying to find a reliable timeline for FDA’s Emergency Use Authorizations (EUA’s). With FDA’s BLA and NDA applications, it’s 10 months or 6 months with Priority Review. But I can’t find anything on EUA’s except for a very general “it can be fast” timeline found on the FDA website (and I know some EUA’s that have taken months, though only like around 3, which is even shorter than Priority Reviews):

“FDA is prepared to issue EUAs expeditiously (e.g., within hours or days) when circumstances warrant and adequate information has been made available for prior review through pre-EUA interactions.”

insert-text-here

So does anyone know timeline/deadline for FDA’s EUA’s—or at least within what period most EUA’s fall into (before 3 months, before 2 months, etc.)?

[Leigh1392]

I have a question re FDA’s approval process for Investigational Device Exemption (IDE). On the FDA website, it says it’ll take 30 days or less to approve an IDE application:

“An IDE application is considered approved 30 days after it has been received by the FDA, unless the FDA otherwise informs the sponsor via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved.”

insert-text-here

However, with some companies, I noticed it takes far longer than 30 days. For example, Check-Cap submitted an IDE application on Oct 9, 2018, but it didn’t receive approval until Dec 13, 2018, which is far longer than 30 days.

insert-text-here

insert-text-here

Why is this? Is this considered normal? Wouldn’t FDA be in violation of its own timeline rules? Please help. I’m trying to figure this out.

[Leigh1392]

I have a question re FDA’s approval process for Investigational Device Exemption (IDE). On the FDA website, it says it’ll take 30 days or less to approve an IDE application:

“An IDE application is considered approved 30 days after it has been received by the FDA, unless the FDA otherwise informs the sponsor via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved.”

insert-text-here

However, with some companies, I noticed it takes far longer than 30 days. For example, Check-Cap submitted an IDE application on Oct 9, 2018, but it didn’t receive approval until Dec 13, 2018, which is far longer than 30 days.

insert-text-here

insert-text-here

Why is this? Is this considered normal? Wouldn’t FDA be in violation of its own timeline rules? Please help. I’m trying to figure this out.

[Leigh1392]

I have a question re FDA’s approval process for Investigational Device Exemption (IDE). On the FDA website, it says it’ll take 30 days or less to approve an IDE application:

“An IDE application is considered approved 30 days after it has been received by the FDA, unless the FDA otherwise informs the sponsor via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved.”

insert-text-here

However, with some companies, I noticed it takes far longer than 30 days. For example, Check-Cap submitted an IDE application on Oct 9, 2018, but it didn’t receive approval until Dec 13, 2018, which is far longer than 30 days.

insert-text-here

insert-text-here

Why is this? Is this considered normal? Wouldn’t FDA be in violation of its own timeline rules? Please help. I’m trying to figure this out.

[chiki]

https://d31dn7nfpuwjnm.cloudfront.net/images/valoraciones/0048/3883/IMG_20220311_233326.jpg?1647038101

[Dennisb68]

EYES, this stock has some great possibilities. Could easily see a 3-4 bagger from here.

https://www.barchart.com/stocks/quotes/EYES

https://ih.advfn.com/p.php?pid=nmona&article=76631540&symbol=EYES

[WHELANer]

What a ride this has been. And I was in this junk over 3 years before this post

[Norm]

Vcel starter position. 2.30 this will be a runner heading into pdufa.

[read_this_n0w]

** ICPT ready ** .. two weeks to FDA adcom panel

[GM_FSJ]

RGBP just gained clearance from the FDA to initiate human trials. Chart set up for big move.

[Stowe]

Rgbp FDA approvel
On December 10, 2015 Regen Biopharma, Inc. (“Regen”) was informed by the United States Food and Drug Administration that Regen has satisfactorily addressed all clinical hold issues related to Regen’s Investigational New Drug Application for HemaXellerate and may initiate a Phase I clinical trial assessing HemaXellerate in patients with drug-refractory aplastic anemia.

[makinezmoney]

$GTHP... FDA Approval

http://www.businesswire.com/news/home/20151202005723/en/Guided-Therapeutics-FDA-Review-Team-Agree-Path

[read_this_n0w]

AMGN.. loaded calls

[The_Free_Nebula]

Adma

[Stock_Gambit]

$ADMD deadline today! Tomorrow expect word!

[RiverNorth]

Thoughts on ADMD?

[basssque]

$IPCI $2.49 +8% and running STRONG!

[basssque]

RNN
Rexahn Pharma (RNN) RX-3117 Data Shows Effectiveness Against Gemcitabine Resistant Human Cancer Cells
9:03 AM ET, 01/06/2015 - StreetInsider

Rexahn Pharmaceuticals, Inc. (NYSE: RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced the online publication of preclinical results for RX-3117 in the peer reviewed medical journal, Anticancer Research, in an article titled, "A Novel Cytidine Analog, RX-3117, Shows Potent Efficacy in Xenograft Models, Even in Tumors that are Resistant to Gemcitabine". The article was coauthored by Dr. G.J. Peters of the VU University of The Netherlands and Rexahn scientists. In this study, the efficacy of orally administered RX-3117 was examined in nine different human tumor Xenograft models that had differing degrees of resistance to gemcitabine. In the four high gemcitabine resistant models gemcitabine treatment resulted in 0% to 30% tumor growth inhibition, whereas oral treatment with RX-3117 induced tumor growth inhibition between 62% to 100%. RX-3117 was also evaluated in a primary low passage Champions Tumorgraft(TM) model derived from biopsy samples from pancreatic cancer patients with known resistance to gemcitabine. In this model, RX-3117 produced a 76% inhibition of tumor growth, as compared to gemcitabine which had tumor growth inhibition of 38%. Dr. Staffan Eriksson, MD, PhD, Professor, Department of Anatomy, Physiology and Biochemistry at The Swedish University of Agricultural Sciences commented, "The Champions Tumorgraft(TM) model used cancer cells, and their microenvironment, taken from individual cancer patients and then transplanted directly into a mouse Xenograft model, making the results potentially more predictive for the outcome of clinical trials. The fact that RX-3117 was active against cells partially resistant to gemcitabine makes these results very promising for future drug development efforts which may be of great benefit to many cancer patients." Peter D. Suzdak, Ph.D., Rexahn's Chief Executive Officer, commented, "The ability of RX-3117 to inhibit the growth of gemcitabine resistant human cancers cells is very exciting. Moreover, the pronounced anti-tumor effects of RX-3117 in the Champions Tumorgraft(TM) model are of particular importance because the cancer cells used in this model are derived directly from biopsies taken from pancreatic cancer patients who have shown gemcitabine resistance. Resistance to the anti-cancer effects of gemcitabine represents a major clinical issue in the treatment of cancer patients. Up to 40% of cancer patients receiving one or more cycles of gemcitabine rapidly become resistant to its anti-cancer activity. Based on study results to date, both preclinical and clinical, we believe RX-3117 holds the potential to be used for the treatment of tumors that do not respond to gemcitabine."

[basssque]

AEMD
Aethlon Medical Announces Approval of Ebola Treatment Protocol

Jan 02, 2015 07:15:00 (ET)

SAN DIEGO, Jan. 2, 2015 /PRNewswire/ -- Aethlon Medical, Inc. (AEMD), the pioneer in developing targeted therapeutic devices to address infectious diseases and cancer, today announced that the United States Food and Drug Administration (FDA) has approved a clinical protocol to treat Ebola-infected individuals in the U.S. with the Aethlon Hemopurifier(R). In the treatment of viral pathogens, the Hemopurifier(R) is a first-in-class bio-filtration device designed for the single-use removal of viruses and shed glycoproteins from the circulatory system of infected individuals. The device targets antiviral drug resistance and serves as a first-line countermeasure against Ebola and other viruses that are not addressed with proven drug therapies.

The approved Ebola treatment protocol allows for an investigational study to be conducted at up to 10 U.S. clinical sites, and up to 20 U.S. subjects may be enrolled to receive the treatment protocol. Patients who meet the enrollment criteria will receive a daily six to eight hour administration of Hemopurifier(R) therapy until the point that Ebola viral load drops below 1000 copies/ml. The goal of the study is to standardize and evaluate the use of the Hemopurifier(R) as supportive care in the treatment of Ebola virus disease.

The Ebola treatment protocol resulted from the submission of a supplement to an Investigation Device Exemption (IDE) previously approved by FDA. The supplement was entitled, "Treatment of Ebola Virus Disease (EVD) in Humans with the Aethlon Hemopurifier(R) Lectin Affinity Plasmapheresis Device." Based on the previously approved IDE protocol, Aethlon is conducting a clinical feasibility study of Hemopurifier(R) therapy in individuals infected with Hepatitis C virus (HCV) who are also receiving chronic dialysis therapy. A detailed description of the HCV study, including treatment protocol and patient inclusion/exclusion criteria can be accessed online at www.clinicaltrials.gov.

As the approved Ebola treatment protocol is a deviation from the HCV protocol, Aethlon is required to clearly distinguish data collected in the supplemental Ebola protocol study from data derived from the Company's HCV trials. The Company may not combine data from the two studies. Aethlon must also comply with specified patient protection procedures established by the applicable institution including its institutional review board approval prior to treating a patient under the supplement protocol. The Company must also report any unanticipated adverse events resulting from the supplement protocol to the FDA within 10 working days of the use of the device. There is no assurance that any Ebola-infected patients will be treated under the protocol.

Aethlon previously reported that Hemopurifier(R) therapy was successfully administered to a critically-ill Ebola patient at Frankfurt University Hospital in Germany. On November 14, 2014, the resulting Hemopurifier(R) treatment data was presented at the American Society of Nephrology (ASN) Annual Meeting by Helmut Geiger, M.D., Chief of Nephrology at Goethe University, Frankfurt University Hospital. Dr. Geiger reported that 242 million Ebola viruses were captured within the Hemopurifier(R) during treatment, a number verified by a post-treatment elution protocol. The elution protocol has since be repeated, which resulted in second measurement of 253 million copies of Ebola virus captured within the Hemopurifier(R).

Dr. Geiger also reported that the patient's viral load prior to the administration of a single 6.5-hour Hemopurifier(R) treatment was measured at 400,000 virus copies per milliliter of blood (copies/ml). A post-treatment viral load measurement was reported to be 1,000 copies/ml. The treatment was well tolerated with no adverse events reported. At the time of treatment, the Ebola patient was unconscious and suffering from multiple organ failure, which required mechanical ventilation, continuous dialysis and the administration of vasopressor medications. The patient has since made a full recovery and returned home to his family.

Time Magazine recently named the Aethlon Hemopurifier(R) to be one of the 25 best inventions of 2014. The magazine also included the Hemopurifier(R) as one of the 11 most remarkable advances in healthcare in 2014.

About Aethlon Medical, Inc.

Aethlon Medical creates targeted therapeutic devices to address infectious disease, cancer and neurodegenerative disorders. The company's lead product is the Aethlon Hemopurifier(R), a first-in-class device that selectively targets the rapid elimination of circulating viruses and tumor-secreted exosomes that promote cancer progression. Exosome Sciences, Inc. is a majority owned subsidiary that is advancing exosome-based products to diagnose and monitor cancer, infectious disease and neurological disorders. For more information, please visit http://www.aethlonmedical.com/ and connect with the Company on Twitter, LinkedIn, Facebook and Google+.

Certain statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, that the ESI will not be able to commercialize its future products, that the FDA will not approve the initiation of the Company's clinical programs or provide market clearance of the company's products, future human studies whether revenue or non-revenue generating of the Aethlon ADAPT(TM) system or the Aethlon Hemopurifier(R) as an adjunct therapy to improve patient responsiveness to established cancer or hepatitis C therapies or as a standalone cancer or hepatitis C therapy or as a broad spectrum defense against viral pathogens, including Ebola, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, the ability of the Company to meet the milestones contemplated in the DARPA contract, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Contacts:

Aethlon Media Contact:

Leah-Michelle Nebbia (for interviews requests)

Golin

202-585-2651

[e-mail]

James A. Joyce

Chairman and CEO

(Office) 858.459.7800 x301

(Cell) 619-368-2000

[e-mail]

Jim Frakes

Chief Financial Officer

858.459.7800 x300

[e-mail]

Photo - http://photos.prnewswire.com/prnh/20090325/LA88762LOGO-b

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/aethlon-medical-announces-approval-of-ebola-treatment-protocol-300014988.html

SOURCE Aethlon Medical, Inc.

/Web site: http://www.aethlonmedical.com



(END) Dow Jones Newswires

January 02, 2015 07:15 ET (12:15 GMT)

[Tutu]

I do

[djpope]

Good heads up madcabbage

AEMD now at $0.52 up +0.10 +23.46% on 17.08m shares the day you posted your alert.

Enjoy dp

[madcabbage]

AEMD Awaiting results for AIDS and HEP-C trials using the hemopurifier, a filter device that pulls viral pathogens out of the blood.
Has already been used to save the life of a Ugandan doctor in Frankfurt Germany who was suffering late stages of Ebola virus contracted while treating sufferers of the outbreak in Sierre Lione. Time magazine has just named the Hemopurifier to its 'Top 25 Inventions of 2014' list.

Results are due by the end of this month/ early December latest.
currently at .42

Who wants to make some money?

[Guy]

KBIO - sold @1.67 for 8% profit.

[Guy]

OREX - sold the rest @5.72 for a 16% profit.

[deadjim]

Cancelled sub here/no private. No problem. Glad someone other than me uses them!

[Guy]

BSDM - Bought in the last few days around .61.
The price has been cut in half in less
than 2 months. The stock is oversold and MACD is starting
to turn up.
They raised approximately $5.2 million @.95 on July 1st.

Insider buys at much higher prices (.82-1.12) in the last few months:
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=10103827
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=9989669
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=9986479
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=9963659

Ablation Technologies Market Expected to Reach USD 10.6 Billion Globally in 2020:
http://www.transparencymarketresearch.com/pressrelease/ablation-technologies-market.htm

[Guy]

OREX - sold half @5.82 for 18% profit.

[Guy]

KBIO - bought @1.55 in the last few
days. Stock is oversold,
stochastics at bottom and MACD starting to turn up.
$59m in cash and a $51m market cap.

http://www.smarteranalyst.com/2014/07/29/william-blair-reaffirms-outperform-on-kalobios-as-sanofi-returns-global-rights-to-kb001-a/

[Rawnoc]

REPR business set to boom based on 7/31/14 news from Baxter:

Baxter:
"FDA Advisory Committee Panel Provides Favorable Recommendation on Baxter’s HyQvia for Primary Immunodeficiency"
"HyQvia is a product consisting of human normal immunoglobulin (IG 10%) and recombinant human hyaluronidase...IG administered subcutaneously, increasing its bioavailability."
http://www.marketwatch.com/story/fda-advisory-committee-panel-provides-favorable-recommendation-on-baxters-hyqvia-for-primary-immunodeficiency-2014-07-31

REPR:
"The FREEDOM60® is popular in the treatment of Primary Immune Deficiency by injecting immune globulin (IgG) under the skin as a subcutaneous administration (SCIg)"
"Competition for the FREEDOM60® for IgG consists mostly of electrically powered infusion devices which are more costly and can create high pressures during delivery which can cause complications for the administration of IgG."
"There is the potential for new drugs to enter the market, containing products such as Hyaluronidase, which can facilitate absorption of IgG, making multiple site infusions unnecessary and changing the market conditions for devices such as the FREEDOM60®."
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=10095834

[Guy]

Bought OREX @4.91. PDUFA on September 11.
The stock is close to being oversold, stochastics
are also way down and previous bottom in April was
around 4.75.

Orexigen Receives Three Month Extension of FDA NB32 Review

SAN DIEGO, June 11, 2014 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (OREX) today announced that the United States Food and Drug Administration (FDA) has extended its review of the resubmitted New Drug Application (NDA) for NB32, the Company's investigational medication being evaluated for weight loss. The new Prescription Drug User Fee Act (PDUFA) action date has been set for September 11, 2014.

The FDA has indicated that the review extension is needed to reach agreement on the post-marketing obligation related to the previously agreed upon evaluation of cardiovascular (CV) outcomes for NB32. The NDA resubmission package includes interim safety and CV outcomes data from the ongoing 8,900 patient Light Study. Discussions around the package insert and other post-marketing obligations are ongoing.

"We are working expeditiously with the FDA to finalize the review," said Michael Narachi, CEO of Orexigen. "We are encouraged by the high level of engagement with the FDA, and are confident that we can reach agreement on the remaining post-marketing obligation."

Orexigen management will host a conference call and webcast to discuss this update today at 8:00 a.m. Eastern time. The live call may be accessed by phone by calling 1 [phone] (domestic) or 1 [phone] (international), participant code 37498115. The webcast can be accessed live on the investor relations section of the Orexigen web site at http://www.orexigen.com/ and will be archived for 14 days following the call.
yhoo.it/1inpkqM

[vinc]

http://www.biopharmcatalyst.com/fda-calendar/

[Rawnoc]

REPR reports kick-butt preliminary results for the second quarter in a row despite it being a seasonally slow quarter.

Sales up 41% to a new all-time record.

Company also added a Baxter and Boston Scientific veteran as COO.

Full results aren't out yet as the quarter just ended May 31. However in the previous quarter with a little bit less revenue it made a solid $0.01 per share. If it continues an annualized run-rate of $0.04 or better, the stock will be a home run from here IMO.

http://finance.yahoo.com/news/rms-announces-increased-sales-organization-192300362.html

[Funstick]

[basssque]

$EDAP is breaking out today
FDA Advisory Meeting scheduled for 7/30/14
http://investor.edap-tms.com/releasedetail.cfm?ReleaseID=850044

[basssque]

$ETRM FDA Advisory Approval after HALT on trading today!
http://finance.yahoo.com/news/enteromedics-announces-fda-advisory-committee-212412782.html

[basssque]

ETRM Target raised to $5.00
http://www.wkrb13.com/markets/322197/enteromedics-price-target-raised-to-5-00-at-canaccord-genuity-etrm/

[alexander77]

EDAP:According to the AF-rule,EDAP should be $12/share.

According to Adam Feuerstein, every biotech company which has an oncology drug in phase 3 and which is nearing FDA decision should have a market cap of 300M at least. I presume this should be also for medical device companies like EDAP, especially when it already approved in Europe and from which the treatment is already reimbursed in France. So with a current market cap of 80M dollar, the share price BEFORE FDA approval should be $12 at least. Please don't forget that this company made net profit last quarter

final FDA decision July 10th

[basssque]

NAVB FDA Approval
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm401085.htm

[basssque]

ETRM has an FDA Advisory meeting on the 17th. Keep an eye on this one!
http://finance.yahoo.com/news/enteromedics-announces-fda-rescheduled-advisory-110000282.html

[basssque]

Gonna throw a few tickers I've been watching closely into the mix here for you guys. These are my favorite plays right now. Make that money!

GALE
NAVB
ETRM
BIOD

[Brain_Bucks]

$ITNS FDA Approval News Today!!! http://ih.advfn.com/p.php?pid=nmona&article=62420058&symbol=ITNS

[Guy]

GTXI - sold the rest @1.53.

[Guy]

Thanks. TRLPF up 20% to 0.80 on FDA
approval. Next is partnership to distribute Natesto.

[swampboots]

Nice play must watch your posts!

[Guy]

TRLPF (.67) - Trimel Receives FDA Approval for Natesto™ Nasal Gel to Treat Men with Low Testosterone

Natesto™ is the first nasal testosterone replacement therapy approved by FDA

TORONTO , May 28, 2014 /CNW/ - Trimel Pharmaceuticals Corporation (TRL.TO) announced today that the United States Food and Drug Administration (FDA) has approved Natesto™ (testosterone), formerly CompleoTRT™, the first and only testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Natesto™ is self-administered via a nasal applicator thereby minimizing the risk of secondary exposure to testosterone of women or children.

"In my practice I regularly encounter men demonstrating symptoms of hypogonadism and physicians will increasingly see this as the North American population ages," said Dr. Jeffrey Rosen , the medical director and founder of Clinical Research of South Florida (CRSA). "For these patients seeking to restore their testosterone levels, Natesto™ will offer an alternative delivery system that is safer and more convenient than the other options currently available on the market."

It is conservatively estimated that nearly 13 million American men may have low testosterone levels. Current treatment guidelines focus on the restoration of the physiological testosterone level through the use of exogenous testosterone preparations, which include topical gels applied by the hands, subcutaneous pellets, transdermal patches, intramuscular injections, oral tablets, as well as a buccal patch.

"The FDA approval for Natesto™ is a major achievement for our company, as it validates our clinical research and development efforts, as well as reinforces our commitment to provide innovative treatment options for patients," said Tom Rossi , Trimel Pharmaceuticals Corporation President and CEO. "Men suffering from "Low T" will now have a different option to raise their testosterone levels. This novel route of administration will enable men to take this therapy in mere seconds, without worrying about the risk associated with transferring the product to women or children. We are now focused on getting Natesto™ to market as expeditiously as possible so that appropriate patients can have access to it."

About Male Hypogonadism

Male hypogonadism, or low testosterone, is a condition in which the testicles, hypothalamus or pituitary gland is affected by disease or damage that results in inhibiting hormone and testosterone secretion. Signs and symptoms associated with male hypogonadism include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, depressed mood, osteoporosis and regression of secondary sexual characteristics.

About Natesto™ (testosterone) Nasal Gel

Indications and Usage

Natesto™ is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone including:

Primary hypogonadism (congenital or acquired)
Hypogonadotropic hypogonadism (congenital or acquired)

Limitations of Use

Safety and efficacy of Natesto™ in males less than 18 years old have not been established

Dosage

Natesto™ for intranasal use is available as a metered-dose pump. One pump actuation delivers 5.5 mg of testosterone. The recommended dose of Natesto™ is 11 mg of testosterone (two pump actuations, one per nostril), applied intranasally three times daily for a total daily dose of 33 mg.

Contraindications

Men with carcinoma of the breast or known or suspected prostate cancer
Pregnant or breast-feeding women. Testosterone may cause fetal harm

Warnings and Precautions

Nasal adverse reactions: nasal signs and symptoms should be monitored. Natesto™ is not recommended for use in patients with chronic nasal conditions or alterations in nasal anatomy
Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH
Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. Evaluate patients with signs or symptoms consistent with DVT or PE
Women and children should not use Natesto™
Edema with or without congestive heart failure (CHF) may be a complication in patients with preexisting cardiac, renal, or hepatic disease
Exogenous administration of androgens may lead to azoospermia
Sleep apnea may occur in those with risk factors
Monitor serum testosterone, prostate-specific antigen (PSA), hemoglobin, hematocrit, liver function tests, and lipid concentrations periodically

Adverse Reactions

The most common adverse reactions (incidence =3%) to Natesto™ observed in clinical trials were an increase in prostate specific antigen (PSA), headache, rhinorrhea, epistaxis, nasal discomfort, nasopharyngitis, bronchitis, upper respiratory tract infection, sinusitis and nasal scab.

About the Natesto™ Phase III Study

Natesto™ was evaluated in a multicenter, open-label, 90-day Phase III trial that enrolled 306 hypogonadal men at 39 clinical research centers in the United States . The mean age of patients was 54 years with a range of 28 to 80 years. Of the 306 patients, 271 (89%) were Caucasian, 18 (6%) were African-American, 16 (5%) were Asian, and 1 (less than 1%) had race recorded as "Other." Patients were instructed to administer Natesto™ intranasally. During the Natesto™ treatment period (Days 1 to 90), 78 patients were treated with 33 mg of testosterone daily. Of these, a total of 73 men were included in the statistical evaluation of efficacy on Day 90 based on the intent-to-treat (ITT) population with last observation carried forward (LOCF). Ninety percent (90%) of these patients had Cavg within the normal range (300 to 1050 ng/dL) on Day 90. The percentage of patients with Cavg below the normal range (less than 300 ng/dL) on Day 90 was 10% and no subject had a Cavg value exceeding 1050 ng/dL.

About Trimel

Trimel is a specialty pharmaceutical company actively developing medications for male hypogonadism, female sexual dysfunction and various respiratory disorders. For more information, please visit www.trimelpharmaceuticals.com.

[Guy]

GTXI (1.56) - up 8%. Taking the 13% profit here
on half my shares.

[Guy]

TRLPF - Trimel Pharmaceuticals Announces Positive Phase II Results for Tefina™
Women treated with Tefina™ 0.6 mg reported a statistically significant increase in orgasms versus placebo
PR Newswire
Trimel Pharmaceuticals Corporation 1 hour ago

TORONTO, May 28, 2014 /PRNewswire/ -- Trimel Pharmaceuticals Corporation (TRL.TO) announced today top-line results of its Phase II clinical trial evaluating the efficacy and safety of Tefina™, a "use-as-required" testosterone nasal gel for the treatment of Female Orgasmic Disorder (FOD). FOD, also known as anorgasmia, is characterized by a delay, absence or reduced intensity of orgasm, causing clinically significant distress.

The double-blind, placebo-controlled study enrolled 253 pre- and post-menopausal women experiencing acquired FOD in the United States, Canada and Australia. Participants were randomized to one of three dosage strengths (0.6 mg, 1.2 mg, 1.8 mg) or a placebo group and treated over the course of 84 days. The primary endpoint of the study was to compare the effects of the three dose strengths of Tefina™ nasal testosterone gel to placebo on the occurrence of orgasm. Secondary endpoints included the change from baseline in distress due to orgasmic disorder, change in sexual functioning and sexual event satisfaction. Safety and tolerability were also assessed.

Tefina™ 0.6 mg led to a statistically significant increase in the average number of orgasms during the 84-day treatment period of 2.3 versus 1.7 for the placebo arm (p=0.0015). In addition, improvements in all of the secondary endpoints were observed; however, further analysis is underway to assess statistical significance. Tefina™ was found to be well-tolerated with no reported serious adverse events.

"Female Orgasmic Disorder is the second most prevalent sexual disorder affecting women. Approximately one in five women report difficulty with orgasm and one quarter of these show marked distress, a key criterion in a clinical diagnosis," said Dr. Sheryl Kingsberg, the U.S. principal investigator for the Tefina™ Phase II clinical trial, chief of behavioral medicine at University Hospitals Case Medical Center and professor of reproductive biology and psychiatry at Case Western Reserve University in Cleveland, Ohio. "Currently, there are no approved pharmacological treatment options, leaving an unmet need that Tefina™ hopes to remedy."

"These results mark an important milestone in the development of Tefina™," said Tom Rossi, Trimel President and CEO. "They provide further evidence that Tefina™ could represent an important treatment option for the many women who suffer from this disorder. On behalf of Trimel and its various stakeholders, I am extremely excited about this positive outcome and look forward to advancing this product towards commercialization."

Investor Event

Trimel is pleased to announce that it will host an Investor Event on Thursday, June 12, 2014, from 12:30 - 3:00 p.m. (Eastern Daylight Time) to provide a more in-depth review of the Tefina™ Phase II study results. Dr. Kingsberg, U.S. principal investigator for the Tefina™ Phase II clinical trial, will be the keynote speaker at the event. The Investor Event will be held at the Toronto Region Board of Trade, First Canadian Place, Suite 350, 77 Adelaide Street West, Toronto, Ontario and by webcast. For more information or to register for the event, contact [e-mail] or visit http://trimelpharmaceuticals.com/Investors/Investor-Day. In-person space is limited.

[Norm]

started board to share catalyst plays:

http://investorshub.advfn.com/boards/chair_board.asp?board_id=25924