And they hired a consultant with a Former FDA Senior Executive that wrote CPI policy? They should have advised them to write the FDA and request a CRL or withdrawal application. What a bunch or morons. This looks like failure by design and someone should be held ACCOUNTABLE.
Market cap is below annual sales. Fwd. PE is $3.00 per share. Hillbilly sell-off will end soon. Couldn't resist to pick up another 10k shares. Thanks.
I see Q2 Earnings to be released 8/14/14 ~ 2 weeks away. This might get back to 3 or go to 2 depending on results and guidance.
The company has MOMENTUM and last quarter net EPS was .05 Even without momentum, the 2014 EPS is .20 per share over 12 months. A forward PE of 15 = $3.00 per share.
Selling at these levels is a giving your money away. Good luck.
Of course there will be the over-reaction to take this to $2 or less (40 Mil Market Cap) over the ADCOM circus act. What a complete sham to be a zero vote on safety. They should pull out of any further attempts with any US Approval and refocus on penetrating new world markets with Ablatherm, FOCAL1 and Lithotropsy.
Anyone that knows anything about this company understands that their FOCAL1 product is the new product successor that is much better anyway. The French will help their own with new medical reimbursement, especially after a US debacle
Sales were 10 million in Q1 with Net EPS .05. and GAINING MOMENTUM with the new product release of FOCAL1. They will easy net 20 cents per share for 2014
BTW The Cleveland Clinic Canada uses HIFU and prefers Ablatherm over Sonablate. Cleveland clinic promotes this as very safe and effective. Cleveland Clinic USA will have to send
NVESTIGATIONAL TREATMENTS: HIFU (HIGH-INTENSITY FOCUSED ULTRASOUND)
High-Intensity Focused Ultrasound (HIFU) is a new treatment currently under clinical investigation for prostate cancer. HIFU uses ultrasonic waves to destroy cancerous tissue.
While this treatment is minimally invasive (no incisions), there are several important limitations:
It is not approved for use in the United States (Not FDA Cleared).
Patients must travel to hospitals outside the United States to receive this treatment (unless the procedure is performed as part of clinical investigation). Some patients travel to Mexico or the Caribbean for treatment.
It is not approved nor covered by Medicare or most US health insurance companies.
HIFU costs $30,000-$35,000 (patient pays the full cost of the procedure plus travel outside of US for treatment).
The patient often must have additional prostate surgery (TURP or Laser) to reduce the size of the prostate prior to HIFU.
There is NO long term data supporting the effectiveness of HIFU.
The success/efficacy, safety, and side effects have NOT been well established for either short or long term use within the United States.
Cryotherapy, however, has been CLEARED by the FDA (Food and Drug Administration) as a minimally invasive procedure. It is covered by Medicare and most insurance companies. Click here to learn more.
Cryotherapy is typically performed on an outpatient basis (patients typically leave the hospital the same day) and only requires one treatment.
American Urological Association;
Best Practice Policy Statement on Cryosurgery for the Treatment of Localized Prostate Cancer
Richard J. Babaian, MD, Chair; Bryan Donnelly, MD, Facilitator; Duke Bahn, MD; John G. Baust, PhD; Martin Dineen, MD; David Ellis, MD; Aaron Katz, MD; Louis Pisters, MD; Daniel Rukstalis, MD; Katsuto Shinohara, MD; J. Brantley Thrasher, MD
"There are no published long-term data on the efficacy of cryosurgery on metastasis-free, prostate cancer-specific, or overall survival as there are with other more established forms of therapy; however, several large, single institution experiences, a pooled analysis, and several prospective evaluation studies report the efficacy and morbidity of cryosurgery of the prostate."
The trend will continue with the new developments, European govt. reimbursements, continued backlog, change in business model. US Approval or not, will NOT stop positive net growth! - FACT
The Center for Devices and Radiological Health has established advisory committees to provide independent, professional expertise and technical assistance on the development, safety and effectiveness, and regulation of medical devices and electronic products that produce radiation. Each committee consists of experts with recognized expertise and judgment in a specific field. Members have the training and experience necessary to evaluate information objectively and to interpret its significance. These persons are not regular employees of FDA, but are paid as "special government employees" for the days they participate as members of a panel. This is time they take from their daily occupations to provide their professional skills to FDA. The committees are advisory -- they provide their expertise and recommendations -- but final decisions are made by FDA.The Center has four advisory committees, including a Medical Devices Advisory Committee which consists of 18 panels that cover the medical specialty areas.
These advisory committee meetings are open to the public, and time is provided for public comment on the topic under consideration. Persons who wish to present their views must contact the executive secretary (listed here as the contact) and request time in advance. For additional information, call the FDA Advisory Committee Information Hotline at 1-800-741-8138.
DNDN is a market failure because it could not ever make a profit on the complexity and enormous expense of ex-vivo immunotherapy. Dilution and market rejection of the enormous cost did this company in.
DNDN market cap was once a company with a market cap of 3.7 billion. What would EDAP's share price be with a market cap of 3.7 billion? (Hint EDAP market cap currently 0.15 billion )
That is the key difference in comparative, QOL with strong incontinence data (has nothing to do with efficacy). FOCAL1 will be the predecessor.
2 quarters of continued LOB backlogs and positive EPS net WITHOUT US Approval. European govt. direct reimbursement Germany and France. Positive net EPS will continue WITHOUT US Approval. Not many biotechs go into ADCOM with positive EPS. This is not speculative and the company does NOT NEED THE USA, IMO.
With that said, the FDA is notorious for game playing with drug approval. However this is NOT a drug, a medical device with 13 years of hard survival data. That's not to say they can't or won't play games, it will eventually get approved in the US and the company will possibly taken out. US needs an HIFU alternative more than HIFU needs the USA.
Anyone else catch this? Former White House National economic council advisor Parrot crafted the sweep while acting in advisory roles to banks? Wonder what that email says that Inside Sources has their hands on?
Big Banks Look To Cash In On Fannie-Freddie Reform Using Washington’s Revolving Door
"Meanwhile, Fannie and Freddie investors are fighting the 2012 Third Amendment – the so-called “Sweep Amendment” – that allows the Treasury Department to seize all profits indefinitely. The restriction exists even beyond the satisfaction of Fannie and Freddie’s debt to taxpayers for the bailout.
One of those who helped shape the amendment is Jim Parrott, a senior fellow at the Urban Institute and former senior advisor at the White House’s National Economic Council. Parrott has served as a consultant for major banks. InsideSources has obtained an email strongly suggesting that Parrott played an advisory role for at least one bank, Bank of America. The email, written by a senior official at the bank, refers to a meeting with Parrott about housing finance reform. In the email, the official also asks about arranging a telephone call to provide details of the Parrott meeting.
Parrott declined to discuss his role with the banks or in the Sweep Amendment discussions when asked by InsideSources. He also chose to not comment on how his work with any banks would fit against the backdrop of the Administration’s internal rules intended to cover political appointees leaving the government."
Search the internet for - EDAP TMS - Ablatherm® HIFU clinical publications. There is a 14 and 15 year study on survival outcomes. Medical device rules under 510 (k) a little different than drug approval.