Yes I agree,
I want to buy a new house and need the down payment. My real estate broker needs to know when response to FDA is completed.
While you're at it Could you get them to also address the manipulation at the opening and the mid-day manipulation. A mid morning manipulation and mid afternoon manipulation deterrence would also be helpful.
Those scenarios would be great and make me a multi-millionaire but $7 a share would make me 70K which is not too shabby for me.
what this or that message board member says is irrelevant.
I must admit I was happy about the pr but upset of the closing price as usual. What does EDAP have to do reinvent the wheel? Hoping that institutions will be loading on soon.
Upside much bigger than downside. Don't forget they already gotten beaten up for the last rejection and FDA later said " this is how you can get approval"
I will give you my opinion of what the "something that is happening here" is. We don't lose all our session gains in the last 1 hour of trading. If we continue to consolidate at this trading range the next run will take us hopefully to the 4's.
Learning to read is a long-term project so I will work on it to reach your educational heights. I just am trying to figure your logic and correlation if there is one between present share price and bits. If this goes up a couple of bits I will probably sell and take a profit so I may make money before reaching your reading level.
So this is a situational stock only dependent on FDA approval? BTW FDA has been known to take less than the 120 guidelines on approval in the past. Depends on workload, if they are already sold on the product and some medical politics I' sure.
Quick crash course in what is a 510(k).
A 510(k) is application for what you’d typically call a “me too” device. Example. Company A has made a device and received a 510(k) clearance to market it from FDA. Company B wants to make a similar device. Company B submits a 510(k) to FDA saying their product is like company A’s and they provide data to demonstrate it’s just as safe and effective as company A‘s device. Once FDA receives the 510(k), they have 90 days to get the initial clearance (approval) or questions back to Company B. There are almost always questions from FDA and when there are questions, a company has 30 days to respond or they can ask for an extension to respond. FDA tries to issue clearances as quick as they can while ensuring compliance of the devices. FDA does have quotas to meet as well after all. 510(k)’s can be for copycat devices of existing devices (although patent infringement may prevent that from happening) and it can be for devices which are similar to existing ones BUT also have new and novel features and characteristics. The biggest takeaway is that a 510(k) does not follow in any way the rigorous review process of a pre-market application (PMA) or a New Drug Application (NDA) like the pharmaceutical companies go through. A 510(k) typically takes 3 – 5 months for FDA clearance. Less
Can we do the same if Sonocare is ahead of the game with approval? We are similar in technique.
I'm confused- do you want me to root for sonocare or not. I know my rooting will make a huge difference.
I can just root for edap or I can root for sonocare to get fda approval then root for them to go bankrupt so it will clear the way for edap which i'm really rooting for.
Also this stock seems to be totally reliant on U.S. approval. Like the rest of the world doesn't matter.
But I could imagine institutional orders from the likes of UCLA, Health South, Kaiser,Mayo Clinic, Clevelad Clinic just to name a few could change the fate of this stock. There is a massive amount of potential and money in the U.S.
Anyone knows how much each hifu machine costs?