stock too cheap at under $100 million.
EDAP TMS SA provided additional details on key events scheduled as part of the U.S. Food and Drug Administration Pre-Market Approval, or PMA, process for its Ablatherm-HIFU device for the treatment of localized prostate cancer. In addition to the previously announced panel of experts that is scheduled to review the Ablatherm-HIFU device and provide a recommendation based on the clinical data submitted to the FDA, the company has additional milestones to achieve as part of the PMA application process. The first relates to an engineering, manufacturing and quality assessment of EDAP's factory, which consists of a routine inspection by the FDA. This has now been confirmed and scheduled to take place June 23-June 26. In parallel there is a clinical data validation process, which includes an FDA audit of the investigation sites. The company has received confirmation and scheduling of the "foreign" site's audit which will be conducted in the course of July. CEO Marc Oczachowski said, "Having dates confirmed for these additional milestones is further great news for EDAP, as it demonstrates how quickly the FDA process is moving for our Ablatherm-HIFU PMA application. We are very enthusiastic to see the progression of events since our last complete submission in March of this year and consider this to be a very exciting time in the Company's history."
same thing will happen to EDAP next 1-2 months after FDA approval.
keep in mind EDAP treatment got EU approval in 2006, but the treatment was still experimental as per EU. Last qtr EU is not recommending this treatment as primary and salvage. All of Europe follows EU guidelines, and do so lot of other asian/latin countries. This will really kickstart sales, and it obvious with their last results (HIFU sales up 130%), profit instead of loss. Plus UE countries are not reimbursing payments for treatment.
Now with US on tast track to approve (they don't want to be left behind Europe), I fully expect approval next 2-3 months, with panel committee meeting on July 30th.
I get my info from their website and recent articles. In 2014 so far they got EU approval as primary and salvage treatment, and not just experimental. They got french reimbursement, others to follow. They reported record earnings and sales last qtr, and strong backlog. US is expediting process of approval with panel meeting on july 30th.
Stock is under 100 mil cap, so is very undervalued given all the developments so far in FY14, and the pending FDA approval hopefully in Q2/Q3. They will be the only HIFU solution for US once they get approval. And people are travelling to Canada to get this done.
Market is starting to see potential here, which is why the spike last couple of weeks. I see EDAP going over 5 by end of July. If news is positive, will see7-8 in next 2-3 months.
this is the FIRST HIFU treatment to be approved in US. This will be used for prostrate cancer and for host of other cancers, WITHOUT THE SIDE EFFECTS of current treatments like removal or radiation. FDA news will be BIG news for EDAP.
this is just the start of Focal One robotic use for HIFU prostate. Expect sales to ramp up in Q2/Q3.
Also, out of the patients that were given this treatement in Germany, 3 were from US ! Looks like US is waiting to get HIFU and Focal One FDA approval.
Just some minor consolidation and profit taking after run up last 2-3 days. Like I said will see $6 before July 31st.
Nothing goes up in a straight line. There are always short team jittery traders along the way.
EDAP submitted application Feb 2013...but since they got EU primary recommendation on April 24th, looks like FDA is accelarting approval with panel recommendation date given on May 22nd (for July 30th), site visits in June, other reviews in July.
Looks like US FDA was waiting for EU to give their clearance, and how they are moving quickly as they feel much for comfortable.
Expect stock to be at $6 by July 30th, expecting a postive recommendation (they have 15 years of clinical data !! Plus Europe, Canada and Asia are using it already), and FDA approval Aug/Sept latest. Stock will go up to $20 again just like EU approval.
Buy on dips.
HAHAHAHA !! You crack me up ! Price 'may' go up if they get FDA approval ! Dude if they get FDA approval stock will go up 200% easy ! When is the last time you saw a biotech/device company not go up after FDA ???
FDA does not care about EU ? Really ?? They why all of a sudden acceleration of reviews/dates since EU recommendation in March ? Check my last post. Check theflyonthewall comments by CEO.
Also EDAP already proved to investors...HIFU revenue up 130% last qtr, profit instead of loss, big backlog, France reimbursement, EU recommendation, which is followed by all of Europe and Asia.
Here are all the details about the upcoming July 30th panel meeting...
they showed very positive results from their initial trial in 2010, and said they planned to start phase II in 2011. They should have some information to share on Phase II very soon IMO.
Also, HIFU has been successfully treated for liver cancer in India...I can't paste the link, but you can search for it on the web.
given the run up....think stock will consolidate a bit since potential FDA approval is still couple of months away.
I don't think so...market cap is already at $148M (its not $130M as shown in yahoo finance). July 30th is just panel recommendation, and stock is already up from mid 3s due to July 30th event.
I agree once FDA approval does come, it may go up to $7-8. But that would be Q4FY14...who knows with FDA.
July 30th is NOT FDA approval. Plus FDA does not need to follow the recommendation either. Look it up.
think there is going to be some profit taking next few days on EDAP. Not chasing here...
this stock is a yoyo....thank Yellen for the cheap shares.
stock will rally tomorrow. AH volume was only 150k...tomorrow total volume will exceed 3 mil.