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I dont think so either CUIN... But just keep in mind the FDA will look at this data closely, especially in light of the increased (and under-reported) AEs related to da Vinci surgeries. You have to remember, the SPORT can work to perfection but there is still chance for human error. I'll probably get blasted for bringing this up but this is what I do... my job is to monitor trials and my top priority is subject safety. There is ALWAYS room for error. I trust Titan, I trust Ximedica, I trust SPORT... I just want to see them get through human trials without the FDA demanding additional safety data - THAT is the greatest rate-limiting factor in my opinion.
http://www.advisory.com/daily-briefing/2013/04/12/fda-launches-investigation-into-da-vinci-complaints
You are right... Conducting a multi-centered human safety trial with a 300+ sample size (if that is the requirement), at hospital-affiliated sites, can be an expensive undertaking!
Nothing is a lock. Ive seen multitudes of device and pharma products approved in the EU but held up here in the US. Dont use CE marking as your guide for approval here. We shouldnt anticipate significant holdups by the FDA unless the safety data is clouded. Everyone should read this FDA teport to understand the differences in the processes.
http://www.pharmamedtechbi.com/~/media/Supporting%20Documents/The%20Gray%20Sheet/38/20/FDA_EU_Devices_Report.pdf
This info could have / should have been released to investors IMO. They announced the Bertner contract, so why not this? It is positive and newsworthy that they are beginning to ramp up sales/marketing contacts in the EU in anticipation of a launch.
They should have used that in the press release today!
Thanks!!!
If that is the case, they will have a smaller "window" of time to either shop the company, find a partner or prepare their own sales and marketing division. I don't see why they couldn't be bringing in potential buyers/partners into discussions now. I doubt anything would be etched in stone until the design is finalized and human trials have at least started. As we move into the Fall / early 2015 and closer to product launch, the telling sign will be whether or not Titan starts to ramp up a sales/marketing force of their own. This is why the recent Joe T. exit is interesting to me. I think they're "shopping!"
lol, very true!
Well said!
I think the argument keeps being made that they don't have an obligation to the stakeholders to keep them informed except to announce milestone completion. That has been the core debate on this board for awhile.
I tend to agree with this analysis. We are all in this at the early stages and CUIN has been in for a few years. While the stock languishes for awhile, there is nothing wrong with him taking a little bit off the Titan table to work elsewhere. He follows the company closely so Im quite sure he'll get back in before we see a considerable spike. I cant get over how everyone continues to be preoccupied with CUIN's money. lol
People should realuze there is a huge difference between constructive criticism and simple bashing of Titan. No one on this board seems to be bashing the company. If one wants to see real bashing, I suggest they go over to the Yahoo board or CafePharma and read a few posts.
This was a good post... You disagreed with CUIN but you were civil about it.
I agree Jemid. Your point is well articulated. But I disagree on the premise that the frustration is being caused by unmet expectations (with a few exceptions). The frustration for most of us is being caused by the lack of respect some have for other individual's investing strategies. This is not a message board for long-term stock holders, it's a messgae board for investors, period! I said it once already today, people ought to worry about their own investments and really just stfu about what other's are doing with theirs. I appreciate ALL points of view in here... but when someone is attacked personally for no reason other than for stating an opinion or asking a question its simply bullshit that wont go unchallenged!
Long, Strong and Diversified!
The term is being used loosely on this board to describe frequent buying and selling on the trend shifts. They are betting on frequent spikes and declines and not future significant increase in pps. Shorting a stock also refers to selling stock that the "seller" doesn't actually own (ie margin accounts with a brokerage house) which is what I think you are referring to if Im not mistaken?
Great post Flenderson!
Again the point being... it's HIS choice to invest the way HE wants to... and HIS right to question anything the company is doing and base HIS investing decisions on the responses to his questions (or lack thereof).
Now, with respect to shorting...
(and I hereby state for the upteenth time, I am not shorting this stock nor any other stock I currently hold)
...where in the iHub TOS does it state that short-sellers are not allowed to contribute to the posting boards? Personally I like to get all perspectives so I welcome their input if it's genuine information. Why the hell are some of the long-term investors on here so damn pompous?
I don't give a rat's ass how people invest... I concentrate on how I invest... Period!
So... if the other blow-hards on here tone it down, I will as well. I only started the recent rhetoric because Im sick snd tired of reading all the baseless bashing of people's investment decisions. To put it bluntly people, mind your own f'n business (decisions).
Good luck TO ALL (Shorties and Lefty included)
What equation are you using to come up with that logic?
Isnt Brazil Gold out of business? Isnt their market cap like $13k. I have more precious metals than that lying around in my backyard. A good speculative play in an established mining company would be something like Coeur D'Alene Mining!
Good luck!
LMAO! This just gets funnier n funnier. Posilock and Suckitup always seem to appear on the board at the same time together to spew their words of wisdom each day. C'mon Posilock, you (two) can make a better prediction than the one you made yesterday. Go out on a limb.
Looks like someone's feelings got hurt yesterday... Aw, poor Hacker!
...and the previous posts you've made about your nephew were only a little bizarre... until now! Brag'n about your 18-month old nephew's "junk" is beyond strange.
btw Hacker, ya ought to look into some psychiatric counseling... your obsession with CUIN2's investment strategy isn't very healthy.
lmao, Okay Lefty!
Lurker, I am speaking for myself but perhaps some of the others would agree, we are not bashing anyone for not being critical of Titan's communication strategy. If you are comfortable with it - all the power to you. By the same token, some of us are defending our positions as stakeholders to be cautious and inquisitive. Merely asking a question like why more specific timeline information cannot be disseminated on a regular basis sets off a firestorm from a handful of Titan investors. We all agree on the importance of timely major milestone completion. There are alot of wheels turning to get to those milestones. Some investors like to stay on top of the day-to-day as much as possible. Others, who rarely contribute ANY pertinent information to the board are the first to jump on people who question what little information is out there. Simply saying "long and strong, stay the course, cutting-edge, game-changer, meeting milestones, etc...) isn't satisfying enough for many investors.
So hey, hopefully some info comes out this week and puts people at ease. If not, its just more of the same.
Ostentatious a$$wipe was begin'n to get on my nerves!
I question MDs / investigators every day in my line of work - and they tend to listen intently and work toward resolutions to avoid being hit with Form FDA 483s or worse yet, charged with fraud. So perhaps you ought to step off your lofty perch, tone down your pretentious "god-complex" and realize there is a plethora of knowledge coming from different perspectives on this board. As stakeholders we have a right to be critical, just as you continue to exercise your right to practice your douche-baggery on this board!
Something tells me youre not much of a surgeon or a golfer because your ginormous head keeps getting in the way. Hate to break it to you and your soon-to-be huge-headed nephew but really "Lefty" you're not "all that" ya hack!
Long n Strong bitches!
Stephen Rosenman should be taken to task on his predictions on Titan as well. It's even worse coming from a self-proclaimed analyst of the industry. I see he pumps the shiz out of Amarin and their "prescription strength" Omega-3 (EPA) product. Not too impressed with the guy but, again, hope he proves me wrong!
Which is why Im put'n him (PosilockSuckitup) on the spot. Time to call "bullshyte" and get this board back to a positive exchange of information/discussion.
Im just bust'n Posilock's chops since he gets all tweaked at people who ask legitimate / critical questions and voice their concerns. People want to maintain some control over their investments in a speculative market. He ought to worry about his 10,000 shares he keeps tell'n us about and stop worrying about everyone else's investment strategies.
EXACTLY!!!!!
Id like to hear his prediction BEFORE an announcement is made. Otherwise, when there is good news, he'll just say, "See, I was right" without having given us some specifics. lol.
Shoot Ill do that do that right now... If there is an announcement/PR from Titan this week, I predict it will have some good news and the stock price will go up!
Damn I should be a market analyst!
True! Posilock, care to elaborate???
Also remember, we don't have a "fozen design" yet. As Point has stated in previous posts, that should be one of Titan's next major milestones and precedes the clinical testing.
Here is the link to the EU Clinical Trials Registry...
https://www.clinicaltrialsregister.eu/ctr-search/search;jsessionid=5TXGCG8s9_tzpDE779d5khBWd3NqzUX5Gxexv-xNHbm-RHEkGrVW!-1763774360
So far I cannot find a EudraCT protocol for Titan/Sport.
Keep in mind, the safety data for the CE marking doesn't necessarily have to come from clinical studies done in the EU.
The Medical Devices Directives state that companies must do the following before they can place the CE Marking on a medical device or IVD:
Compile a medical device CE Marking Technical File (or Design Dossier for Class III) with evidence of compliance to the Medical Devices Directive (or the IVD/AIMD Directives).
Receive a medical device/IVD CE Mark certificate from a Notified Body if Class I with Measuring or Sterile function, Class IIa, IIb, or III, or if Annex II, List A; Annex II, List B, or self-testing IVD.
Appoint a European Authorized Representative if you have no physical location in Europe.
Register medical devices with the EU Competent Authorities, where applicable.
I wish we had a better grasp of the development timeline!
So I ask the Titan investors on this board... Wouldn't it be nice to get some periodic updates on some of these processes? Basic major milestones are the most important points for the casual observer of the stock. But as serious investors, don't you want updates on how the company is progressing between major milestones?
Requirements aren't the same. Im not sure what safety data they need to show for CE Mark but I know they don't have to do extensive clinical studies like they do for approval in the USA. Ill see what I can find out.
But I agree... announcement of successful human trials will most definitely have a significant effect on pps!
As far as I know they haven't begun human trials. For one, the studies would most likely be listed on the ClinicalTrials.gov registry.
lmao!
Hey Posilock / SuckitUp... Still waiting for this week's prediction. What is the grand news that will send the Titan stock price soaring? If you don't want to share that info then at least give us your prediction on the PPS upon this week's pending announcement(s). Will we hit a new high? Will we see $3.00+? Will we maintain above $2.50 - $2.75 until the next leg up?
While I continue to have high expectations for Titan in the long run, I still say not much is going to crank-up pps significantly in the near-term. I also stand by my prediction that eventually the FDA will be our #1 rate-limiting factor (unless a buyout occurs prior to approval). Like I said before, I hope you prove me wrong. I'll be the first to congratulate you if your previous statements and your predictions are backed up this week. I hope you can show us all that you really know something is in the works. Both you and Steve Rosenman very well could be legendary prognosticators by proving all the skeptics wrong! On the other hand, your credibilty could soon go right down the sh*tter!
So, your prediction?
Titan Medical, Inc. is a California Corporation filed on October 6, 2009. The company's filing status is listed as Active and its File Number is C3110854.
The Registered Agent on file for this company is Aaron Jennings and is located at 24631 La Cresta Dr Unit B Dana Point, CA . The company's principal address is 24631 La Cresta Dr Unit B Dana Point, CA 92629.
The company has 1 principal on record. The principal is Aaron Jennings from Dana Point CA.
Titan Medical, Inc in Orange County appears to be an Allied Health Service in Dana Point, CA.
...Overview of Aaron Jennings in Dana Point, CA
Aaron Richard Jennings is the President of Titan Medical, Inc. and holds active roles in two companies and inactive roles in one additional company .
Titan Medical, Inc. filed as an Articles of Incorporation in the State of California filed on Tuesday, October 6, 2009. This corporation is approximately five years old according to documents filed with California Secretary of State.
Aaron Richard Jennings's additional active roles include:
Member of Atlas Medical, LLC
President of Salt Water Holdings, Inc.
Aaron Richard Jennings is connected to other officers through these corporate roles. One of the top connections is Gowriharan Thaiyananthan .
Atlas Medical, LLC also lists Cammedical Device as Member, in addition to Aaron's role of Member. This corporation was registered one year after Titan Medical, Inc. as a Domestic in the State of California on Tuesday, April 13, 2010.
Couldn't have said it better... Thanks CUIN! This board is absolutely worthless without those who continue to be diligent in getting updated information and then analyzing that information (sometimes critically) to spark discussion and debate. To sit on here and bash people for actually giving thought to their investment and continue to simply try to pump every body up with the idea of future riches day in and day out, without critical analysis, is a waste of time.
btw... Margaret Hamburg is the FDA Commissioner.
lol, exactly!