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!