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Not many folks using IHUB anymore. Ping me on StockTwits PapaSmurfIHUB
$APOP - Papa likes the POP part. Watch above 1.08 here. 1.22-1.27 doable.
$AVGR - Eye on .48 above here. Breakout should be coming soon! Target 0.71
$AMPE - .68 quite a resistance. If this breaks above for sure we heading for $1 land. Look for .73 above. Buy under .65 and hold.
It's been a long while! Hope to do some postings in here again real soon!
$YTEN $1.15 super low tradeable float. Jack Schuler owns over 50% of float. Data due any day now. if decent Data 50%+ move is a given. JMO
I think our little blue friend is over on StockTwits. You should invite him back, miss him.
I killed my stocktwits accnt long ago.
Everything alright Smurf?
ADMP Receives Complete Response Letter From FDA for Its Epinephrine Pre-Filled Syringe NDA
http://finance.yahoo.com/news/adamis-pharmaceuticals-receives-complete-response-214144627.html
SAN DIEGO, March 27, 2015 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (ADMP) ("Company") announced that today it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe (PFS) product, for the emergency treatment of acute anaphylaxis, which is a severe allergic reaction. On May 28, 2014, Adamis submitted an NDA to the FDA pursuant to Section 505(b)(2) of the Food, Drug & Cosmetic Act, as amended, for approval of the Epinephrine PFS product.
A CRL is issued by the FDA's Center for Drug Evaluation and Research when it has completed its review of a file and questions remain that preclude the approval of the NDA in its current form. The questions raised by the FDA pertain only to Chemistry, Manufacturing and Controls (CMC) relating to the volume of dose delivered by the syringe, including the ability to deliver volume within the levels contained in the labeling claim and as required by the FDA. No other safety or efficacy issues were raised, and the New Drug Application will remain open until the CMC issues are resolved.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "We are reviewing the CRL and plan to request a meeting with the FDA to discuss the letter, including clarifying the product delivery volume specifications. Although we expect to have more clarity with respect to timing, we believe we can satisfy all of the requests in the CRL and will work closely with the FDA to address the items raised in the CRL and finalize its review of our NDA. Adamis remains committed to bringing the epinephrine PFS to market."
Interesting annotated IBB chart from Jesse Stine.
https://pbs.twimg.com/media/CASTxYSVAAEylFA.png:large
Well it has been about a year and this one finally got great news today:
AOLS Aeolus Receives Orphan Drug Designation From US FDA for AEOL 10150 for Treatment of Idiopathic Pulmonary Fibrosis
"Orphan Drug Designation entitles the sponsor to a seven-year marketing exclusivity period, clinical protocol assistance with the FDA, as well as federal grants and tax credits."
Keep this one on your list. They have a phase one cancer trial coming up for the effects of radiation on the lungs. Lots of good stuff ahead here.
http://finance.yahoo.com/news/aeolus-receives-orphan-drug-designation-154629158.html
ADMP $5.90. Not currently in. Got shaken out on move up. Down recently on insider sell? Major news expected one way or the other this month. If good news would expect this to be significantly higher. Completed financing earlier this year at 5.00. Feel like I need to at least have a toe in the water here or be very disappointed. This move down is scary making me feel like someone knows bad news coming, but it also reminds me of final shakeout before giant news and huge run. Something like DNDN back in the day if I remember right. Market seems to like getting as many people out before a move as it can. We'll see.
$ZGNX $CPRX $SNSS
$ZGNX - $1.72 with vol. Will send this to $2. Watch.
I think he is day trading and abandon this :(
ELTP has been getting lots of action this week. Still waiting for my profits, I over brought at @ .52, hopefully it can go over that soon!
Where's the Smurp?
(Serious question)
ETRM. Good timing. I see Sheff bought back today. Helps a little.
Also hope you do well with ETRM. I'm feeling a little sick to my stomach at this point with it!
Thanks for the mention of IPCI. It had fallen off my watch list.
BNHLF (MC $33 M) BLA Filing for BIG Bladder Cancer vaccine in this Quarter .
Runup to FDA decision and Approval could drive this Stock close or over $2 per Share ! GL
Market Cap: $33 Million
Cash: $10 Million
Price: $0.19
Presention fron last month
http://www.bioniche.com/pdf/2014/CEO%20Presentation%202014%20Annual%20General%20Meeting.pdf
Bioniche will file BLA with the US FDA, seeking approval for the commercialization of MCNA based on existing clinical data; Target filing date: Q1/2015 . Near term revenue opportunity in the U.S
Potential for marketing approval as early as end of 2015/early 2016 .Exploring potential for US listing .
Pivotal phase 3 study (completed) shows it can delay (or prevent) need for cystectomy (bladder removal) in 25% of patients with high-risk non-muscle invasive bladder cancer (NMIBC) who failed first line BCG treatment
Supported by strong intellectual property coverage
•Patent term expiration: 2031
•Automatic 12 year market exclusivity for novel biologic in US
Of all cancers, bladder cancer has the greatest lifetime treatment cost per patient diagnosed (US, 2010)
$230,000 . 80,000 new cases/year in North America .
Potential for peak U.S. sales of $200M plus .Comparable or greater market opportunity ex-US
•NMIBC BCG-failure population only
•50% market penetration
•$3,000 per dose
$TRRE..Oh my!>>>>>Revs up 341%, $700,000 Gain in only 9 months....
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."
Interesting chart showing small caps could be place to be...
http://stocktwits.com/InsiderBuySuperstocks
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
lnebbia@golin.com
James A. Joyce
Chairman and CEO
(Office) 858.459.7800 x301
(Cell) 619-368-2000
jj@aethlonmedical.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
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)
Tax loss selling bounce candidates?
I've seen KBIO mentioned this morning. I see RGDX got spanked today and I'm sure there are a lot of losses there. Not sure if it has a bounce in it however.
ANV ($1.04 close). That would have turned out well.
Andrew, I think that's actually a good idea. There is nothing scientific about this, but last week my wife texted me during the day after filling up her car with gas (usually I do this) and she was super excited that she filled up for $40.
Her excitement has to be a sign of a bottom!
Not sure about the immediate future, but over the long haul, I'm not sure how those could be bad trades.
Hey there Hesse! Have you considered any oil positions like Shell or Chevron? Safe dividend paying stocks? I'm finally considering it.
CYTX ($0.51). Looks interesting. I don't own this but understand they had some good news last week.
http://scharts.co/1stT8Hk
Morning Smurf, Ned, Andrew etc. Hope all is well with everyone!
current positions: IAG, ADMP, FLCR
Looking to rebuild my watch list. Any ideas are welcome! ELTP would be one on watch list but haven't followed for a while. Noticed a lot of CTIX talk this morning.
Smurf - are you playing CTIX?
OREX should run much higher today. http://finance.yahoo.com/news/orexigen-therapeutics-reports-results-third-120000485.html
Great future potential for WLT and ANR
After the election coal is the hot sector
I got in PXYN at .062. Expecting a run up.
Hrtx. Nda resubmission soon. Got in low 7's and exited just below 8 trying to swing...this should move by end of year. Exited way to early looking to get back in
Wlt tempted to take a position with tight stop. May not be a bad idea to leave some profits in for long term?
PLUG - Better unplug this one @$4.71. Other option hold it through next week and risk to see if it might hit $5.05.
CLF - Totally missed this ride.
GST - Would of gained about .30c if entry was $3.70 now $4 tagged. Let some go but keep some for next ride breakout.
WLT - Time to exit a portion if you added earlier with the dips.
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