building for days of fishing
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1 in every 5000 biotech companies make it into and through the fda process when you consider those also trading at 00 the odds are probably one in a million. many of us have thrown a lot of money at this company I myself have lost over $8,000 it is time to move on.please do not put any more money into koos hands its going nowhere
the last couple weeks biotech companies have been getting slammed and failing with the FDAand these are companies that are in the five to ten to twenty dollar range not one tenth of a penny
just like that drops 1.05 from ten minutes ago high of day. this is gonna be crazy action leading up to nov. 12th earnings report and if they prove numbers are verifiable. might re enter but not for over 10.00.. If i had to predict id say this sees 14.00 or more by then but its scary with muddy waters slinging mud
hindsight is tough. whats not is taking a profit and not looking back. cash in account does not swing dip or disappear on hindsight
yeah i flipped it from 10.40 to 11.23... looking for high nines to try again...
saying this will be the same story line is as unfair and wrong as if it is the same end game. we simply do not know yet and id bet you went short. time will tell
meaning? u think it tanks to that by friday? or november u purchased a future for that amount. yikes thats risky
yeah my bad. nq got bullied by muddy waters but i feel they will prove these claims as false and we see 15.00 to 16.00 this wk
if nq proves the muddy waters claims as false and files lawsuit against them we will regain our value and then some. time will tell but im shocked at how getting 174 million settlement from q comm is a bad thing
and when regen comes out at double zero something and the o/s gets scheduled for more dilution you will say>>>>>>>>>>>>>>>>>>>>>>>>>
if 2 percent of this company was real we would be at .05 its all nonsense lies scam of the scams they couldnt cure hiccups let alone breast cancer. koos will get his in the end. uncle guido guarantees it
lol are you serious lol omg
wow now everyone sounds pathetic. If this was a scam it would of tanked again today to teens. Theres buying thus still hope
whats normal about 003
It will start out looking strong but the group who paid the 30k will be dumping like mad along with koos diluting and the first sign of disappointment will crush all the cards holding this house together and it ends the day at .0026,mark it stay thristy my friends
21k CASH has traded hands today in a company that is about to skyrocket into a 1 in 5000 lotto chance and a sure fire big pharma must have little gem. worse then that of the 21k 70 percent was me lol BMSN BMSN BMSN
So of the 5000 applications the fda has decided bmsn is the one and only. why? koos? solid history of drugs? cash position? oh please dont say cause of suhy. I pray it gets approved and my last million shares makes me back some of my losses but ENOUGH
l Process
The FDA Drug and Biologic Approval Process: A hot topic
The high cost of prescription drugs is a hotly debated issue and poses a significant burden to individuals, families, and the federal government. Drug costs have led to Medicare Part D, a federally subsidized program meant to defray the costs of prescription drugs, particularly to the elderly. Though there are many contributing factors drug prices, their expense is due in part to the cost involved in completing the FDA approval process.
In order for pharmaceutical and biotech companies to market their drugs and biologics, companies must receive FDA approval, a rigorous, expensive, and time consuming process that can take over a decade to complete. Of 5000 compounds discovered in the pre-clinical stage, only about 5 will make it through the entire FDA approval process. Therefore, companies have to cover not only the cost of successful development of a single drug, but of many drugs that never make it to market.
The Phases in the FDA Approval Process
Pre-Clinical Phase
In the pre-clinical or drug discovery phase of the approval process, researchers look for potential new compounds to treat targeted diseases. Once a compound has been identified and refined to a formula that can be tolerated by humans, its toxicology is tested in animals and living tissue. The process takes roughly three and a half years. During this phase researchers look for:
correct dosage level
how frequently it should be administered
the best delivery system (oral, topical, intravenous, etc.)
short- and long-term survival of the animals
After pre-clinical testing is completed, the company then files an Investigational New Drug Application (IND) with the FDA. Fast Track Designation is an expedited review of a drug that is given to a company whose drug or biologic makes both a product and a marketing claim that addresses an unmet medical need. It can be granted at any point after the FDA approves an IND.
Phase I
If the FDA approves the IND, the experimental drug then moves into Phase I human testing. In this phase, the drug is tested in a small number (under 100) of healthy participants. Researchers look to see how well the drug is tolerated, how it is processed by the human body, and the correct dosing. This process takes a year.
Phase II
Once a compound is found to be well tolerated in healthy individuals, it is then tested for effectiveness for a targeted disease in a small number of patients. In this phase 100-300 people are administered the investigational drug to see if it actually works, and to determine its short-term effects. This process takes about two years.
Phase III
Phase III is a large-scale study of the effectiveness and side effects of the drug in a larger population, usually ranging from 1000-3000 patients. If the drug is submitted to the FDA for approval, the FDA will look at the Phase III data to determine if the drug is safe and effective. Aside from testing the drug’s viability, the company producing the drug also determines the logistics involved in creating a large supply of the treatment. Phase III of the FDA approval process takes about three years.
New Drug Application (NDA)/ Biologics License Application (BLA)
If the drug proves to be safe and effective, the company then files an NDA or BLA with the FDA. NDAs and BLAs are typically 100,000 pages long and include results of human and animal trials as well as information on how the drug is manufactured. It usually takes the FDA 1-2 years to complete the review process and approve a drug. However, there are cases when approval can be accelerated.
At the time of application Priority Review can be granted to drugs that treat an unmet medical need.
Orphan Drug Status is granted to drugs that treat rare diseases, or diseases that have no other available treatments.
Phase IV
Once a drug has received FDA approval it is then marketed to the general population. Short- and long-term side effects continue to be monitored and results are submitted to the FDA. Companies will also look for additional indication for the drug. In order for the drug to be approved for a new indication, it must receive approval from the FDA.
FierceBiotech is a free daily email newsletter that keeps you up to speed on important clinical trial developments, New Drug Applications, and FDA approvals. We pay special attention to the business side of clinical trials. The newsletter tracks advances in pharmacogenomics and screening techniques, venture capital investments in drug development companies, key initiatives from the NIH (National Institutes of Health) and other organizations, and companies' efforts to advance their clinical trials pipelines and bring new drugs and treatments to market.
Sign up for FierceBiotech today -- get clinical trial updates and FDA approval information that help you save time and get ahead!
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THE LIBRARY: RESEARCH
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When planning your oncology clinical trial, you rely on trial experience, scientific expertise, reliable independent review, and trial-specific imaging endpoints. As the world's largest imaging core lab, BioClinica has the expertise you want and the medical imaging solutions you need to successfully support your oncology clinical trial. LEARN MORE >>
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no bro they do not. The big boys are doing battle with fda on their own products. bmsn has nothing to offer the big boys come on man enough
i kept 1 million just in case But enough nonsense all ready. company keeps us in dark . who cares if press release isnt the grand daddy of all any update would be better then being ignored. I call them never get a answer or call back and 1000 unreplied emails ENOUGH
everyone here said do your dd. well i did and the truth be told 1 out of 5000 get fda approval to start 5 make it thru trials and it takes decades. pray for more hype and a bullshit pr then bail
LOL. so three major companies have shown progress in clinical trials one being pfizer but they closed his plant down so being the wise man he is he saw bmsn and said oh yeah baby thats for me. lol or was he just unemployed
SEE WHERE IT SAYS DECADES AND THAT OUT OF 5000 ONLY FIVE WILL GET APPROVAL? AND ANOTHER 3 BILLION TO FLOAT???? YEAH OK
l Process
The FDA Drug and Biologic Approval Process: A hot topic
The high cost of prescription drugs is a hotly debated issue and poses a significant burden to individuals, families, and the federal government. Drug costs have led to Medicare Part D, a federally subsidized program meant to defray the costs of prescription drugs, particularly to the elderly. Though there are many contributing factors drug prices, their expense is due in part to the cost involved in completing the FDA approval process.
In order for pharmaceutical and biotech companies to market their drugs and biologics, companies must receive FDA approval, a rigorous, expensive, and time consuming process that can take over a decade to complete. Of 5000 compounds discovered in the pre-clinical stage, only about 5 will make it through the entire FDA approval process. Therefore, companies have to cover not only the cost of successful development of a single drug, but of many drugs that never make it to market.
The Phases in the FDA Approval Process
Pre-Clinical Phase
In the pre-clinical or drug discovery phase of the approval process, researchers look for potential new compounds to treat targeted diseases. Once a compound has been identified and refined to a formula that can be tolerated by humans, its toxicology is tested in animals and living tissue. The process takes roughly three and a half years. During this phase researchers look for:
correct dosage level
how frequently it should be administered
the best delivery system (oral, topical, intravenous, etc.)
short- and long-term survival of the animals
After pre-clinical testing is completed, the company then files an Investigational New Drug Application (IND) with the FDA. Fast Track Designation is an expedited review of a drug that is given to a company whose drug or biologic makes both a product and a marketing claim that addresses an unmet medical need. It can be granted at any point after the FDA approves an IND.
Phase I
If the FDA approves the IND, the experimental drug then moves into Phase I human testing. In this phase, the drug is tested in a small number (under 100) of healthy participants. Researchers look to see how well the drug is tolerated, how it is processed by the human body, and the correct dosing. This process takes a year.
Phase II
Once a compound is found to be well tolerated in healthy individuals, it is then tested for effectiveness for a targeted disease in a small number of patients. In this phase 100-300 people are administered the investigational drug to see if it actually works, and to determine its short-term effects. This process takes about two years.
Phase III
Phase III is a large-scale study of the effectiveness and side effects of the drug in a larger population, usually ranging from 1000-3000 patients. If the drug is submitted to the FDA for approval, the FDA will look at the Phase III data to determine if the drug is safe and effective. Aside from testing the drug’s viability, the company producing the drug also determines the logistics involved in creating a large supply of the treatment. Phase III of the FDA approval process takes about three years.
New Drug Application (NDA)/ Biologics License Application (BLA)
If the drug proves to be safe and effective, the company then files an NDA or BLA with the FDA. NDAs and BLAs are typically 100,000 pages long and include results of human and animal trials as well as information on how the drug is manufactured. It usually takes the FDA 1-2 years to complete the review process and approve a drug. However, there are cases when approval can be accelerated.
At the time of application Priority Review can be granted to drugs that treat an unmet medical need.
Orphan Drug Status is granted to drugs that treat rare diseases, or diseases that have no other available treatments.
Phase IV
Once a drug has received FDA approval it is then marketed to the general population. Short- and long-term side effects continue to be monitored and results are submitted to the FDA. Companies will also look for additional indication for the drug. In order for the drug to be approved for a new indication, it must receive approval from the FDA.
FierceBiotech is a free daily email newsletter that keeps you up to speed on important clinical trial developments, New Drug Applications, and FDA approvals. We pay special attention to the business side of clinical trials. The newsletter tracks advances in pharmacogenomics and screening techniques, venture capital investments in drug development companies, key initiatives from the NIH (National Institutes of Health) and other organizations, and companies' efforts to advance their clinical trials pipelines and bring new drugs and treatments to market.
Sign up for FierceBiotech today -- get clinical trial updates and FDA approval information that help you save time and get ahead!
Sign up for FDA News & Issues - it's FREE
back to Biotech Company News
Join 100,000+ Insiders SIGN UP FOR OUR NEWSLETTER
FierceBiotech is the drug development industry's news monitor, covering biopharma deals, clinical trials, FDA decisions, and more. Subscribe to our free daily email and join the largest, most influential biotechnology news audience in the world. Sign up today!
Popular Stories
Most Read
Most Shared
UPDATED: San Diego biotech insider accused of shooting RNAi expert and brother-in-law
Merck's Perlmutter shares plans for R&D reboot, likes and dislikes
Ablynx lands $840M AbbVie deal on next-gen Humira successor
Merck R&D hammered by another setback as FDA rejects anesthesia drug (again)
Roche lung cancer drug bags another 'breakthrough' at the FDA
THE LIBRARY: RESEARCH
The Right Experience for Oncology Clinical Trials
| Sponsored by: BioClinica
When planning your oncology clinical trial, you rely on trial experience, scientific expertise, reliable independent review, and trial-specific imaging endpoints. As the world's largest imaging core lab, BioClinica has the expertise you want and the medical imaging solutions you need to successfully support your oncology clinical trial. LEARN MORE >>
MORE ITEMS
Latest Commentary
Next FierceBiotech Event: 'Big Data Gets Smart'
Regado CEO moves the goal line after a rare biotech IPO misfire
FierceBiotech coming to iPhone and iPad this fall (sign up for early notification)
My next mission: Sharing discoveries from Novartis
UPDATED: No end of biotech IPO frenzy in sight
EVENTS
US Conference on Rare Diseases and Orphan Products: The New Era in Health CareOctober 7-9 — North Bethesda, MD
FierceBiotech Executive Breakfast: Big Data Gets SmartOctober 15, 2013 — Boston, MA
BioImmersion Three-Day CourseOctober 16-18 — Washington, D.C.
MORE EVENTS
Read more: FDA Approval Process - FierceBiotech http://www.fiercebiotech.com/topics/fda_approval_process.asp#ixzz2fjlclTXL
Subscribe at FierceBiotech
ENOUGH. ONE OUT OF 5000 FDA REQUESTS GET APPROVED BMSN A PIPE DREAM
gs in Clinical Trials Offer New Hope
By Minyanville, August 01, 2013, 10:00:00 AM EDT
Vote up
Several companies appear to be on the verge of making a significant breakthrough in the treatment of breast cancer. This is a medical area that has certainly seen improvement over the past decade but is still searching for answers. The American Cancer Society estimates that there will be 232,340 new cases of breast cancer diagnosed among women in 2013. There were also an estimated 39,620 deaths among women during the same year. The chance of a woman having breast cancer sometime during her life is about 1 in 8. Currently, only lung cancer accounts for more cancer deaths among women. These statistics have been so alarming that foundations and philanthropists have spent hundreds of millions of dollars on breast cancer research over the past decade. Investors looking to make an early investment in this area should strongly consider the below companies that appear to be close to offering hope to millions of women.
The first company that is getting close to a treatment for breast cancer is Celldex Therapeutics ( CLDX ). Celldex is a biopharmaceutical company focused on the development and commercialization of several immunotherapy technologies for the treatment of cancer and other difficult-to-treat diseases. Shareholders in Celldex have enjoyed share price appreciation of more than 300% over the past 12 months. The company has soared on expectations that its deep drug portfolio will continue to grow and eventually receive approval. The product candidate that seems to have the most potential is CDX-011, which is currently being evaluated in the EMERGE trial. CDX-011 is an antibody-drug conjugate that targets glycoprotein NMB. This is a particular type of protein that is overe-xpressed by various types of tumors, including breast cancer and melanoma. Thus far, the company has had extremely encouraging results. In December 2012, Celldex reported final data from the Phase II study. The trial results supported overall survival benefit in patients with high GPNMB expression. The next steps for Celldex include evaluating CDX-011 in patients with GPNMB over-expressing triple-negative breast cancer in an accelerated approval registration study. This study is expected to begin by the end of the year.
A second company that has shown an incredible amount of promise thus far in its trials is Galena Biopharma ( GALE ). Galena is a biopharmaceutical company focused on developing oncology treatments to address major unmet medical needs to advance cancer care. The company has developed a deep pipeline of immunotherapy product candidates based on the E75 peptide . Currently, the company is focused on evaluating Neuvax, which is used in the treatment of breast cancer and other tumors. Galena has had a series of positive press announcements since December of last year. On December 4, 2012, Galena announced an agreement with Teva Pharmaceuticals ( TEVA ) to commercialize Neuvax in Israel. This agreement will allow Galena to save a great deal of money and time as Teva will handle the development and regulatory process in Israel. Galena expects to receive a significant amount of royalty revenue from any and all eventual sales in Israel. Another positive press release was announced on December 7, 2012. Galena was presenting at the San Antonio Breast Cancer Symposium when the company revealed its data from the Neuvax Phase 1 and II trials . The data was overwhelmingly positive and demonstrated a more-than-acceptable safety and efficacy profile. Remarkably, Neuvax showed a 5.6% recurrence rate vs. a 25.9% recurrent rate in the control arm. This represents a recurrence reduction of 78.4%. In addition to their breast cancer product portfolio currently in development, Galena intends to launch Abstral in the fourth quarter of this year. Galena acquired Abstral on March 18, 2013 . Abstral is a rapidly acting tablet used in the management of breakthrough cancer pain in opioid tolerant patients. The breakthrough pain market generated sales of approximately $400 million in the United States during 2012. Given that the size is much larger across the rest of the world, Galena stands poised to capture a significant portion of this market, which will serve as a nice bonus and a way to continue funding their breast cancer trials.
The third company, and certainly the largest company, that is getting closer to a treatment is Pfizer ( PFE ). Pfizer has developed a compound called palbociclib, which is an oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6. In pre-clinical studies, palbociclib was shown to be an inhibitor of cell growth and a suppressor of DNA replication by preventing cells from entering S phase. On April 30, 2013, Pfizer announced that palbociclib received Breakthrough Therapy designation by the United States Food and Drug Administration for the potential treatment of patients with breast cancer. Pfizer has already initiated a Phase III trial to gather more data for the FDA. Currently, Pfizer is working with the FDA to determine the next steps in order to stand the best chances for receiving approval.
Synta Pharmaceuticals ( SNTA ) is another potential player in the breast cancer treatment industry. The company recently announced positive results from its ENCHANT-1 clinical trial . The trial evaluated ganetesib monotherapy in patients with newly diagnosed locally advanced or metastatic HER2 positive or triple-negative breast cancer. Synta now plans to advance the drug to the next stage of the trial with hopes of enrolling a total of 33 patients per cohort.
All four of these companies appear poised to play a large role in developing breakthrough therapies for the treatment of breast cancer. Although still a ways off from facing the FDA in hopes of receiving approval, the companies do appear to making solid progress. As always, investors need to remember that these trials are experimental and nothing is guaranteed, no matter how strong the data appears. That being said, investors looking to make an early investment in this space should strongly consider these companies.
Editor's note: TM Meyer is a former equity derivatives market maker based out of Dallas. He currently manages his own personal portfolio using a combination of fundamental analysis, technical analysis, and event driven catalysts.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.
This article appears in: Investing , Stocks
Referenced Stocks: CLDX, GALE, PFE, SNTA, TEVA
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bio techs are risky plays thus the caution combined with peoples distrust of koos . The increased float possibilities do not help either. BUT it really is setting up nicely for a sustained large increase in pps in the near future instead of a pump and dump . Just hope when news hits koos is shareholder friendly enough to do the cussip change
well hopefully fda news and cussip change will happen before november. dont know what else to say. sick of the trumpets and the doom and gloom.. come on koos give it to us straight
was that 2.1 million at .0032 a buy from anyone here? or new interest i wonder
and it closes green your welcome
and another ask slap by me. Why? im not sure gambleholic i guess
I hit the ask twice porky but it seems im not getting any help
guess not sigh
There i bought 49k on the ask hope it stays green lol
i turned 1400 into 236 on this lousy play. oh well good write off and lesson
dead board? no kidding i bought into this turd at .01 garbage company
This just in from colfax capital on twitter " sec charges 23 firms with shorting into offerings" hmmm looks like the time for cussip change couldn,t be better
If its true that they were successful in treating breast cancer in animals then that is an amazing press release
And thats supposed to mean this giant of a company wants no wait NEEDS koos and his .0029 five billion team of the worlds greatest minds to accomplish this rotflmao oh my god
Shorts were covering and the price went down? and here I thought It was supposed to work the other way
could it be because they got F da approval and we didn't yet?
or could it be because their management team cares about their shareholders and ours doesn't?they did a cussip change and stopped all the manipulation have we? of course not