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(3) Titan Insider Trading Policy
32. Titan’s Insider Trading Policy (the “Insider Trading Policy”) prohibited directors,
officers and employees and any person in a special relationship with Titan from buying
or selling securities of Titan while having material information that has not yet been
made public and required directors and officers to seek approval from Titan prior to
trading shares of Titan.
There is a minimum of 7 companies that NEED to get into robotics that aren’t in it. If they don’t , they will be crushed over the next 10 years. And there is one company ISRG, that should do all it can to protect its business and widen its moat. If they lock up SIngle Port for 10 years they ensure their survival. Owning Titan would lock up 2 ways u can do single port robotics. Titan is worth 10’s of Billions to ISRG. To get Titan for $3B right now would be a steal for them and quite honestly a no brained. Intuitive can’t let JNJ or Medtronic to get a single port system. Let alone one with a patent for a camera on the insertion tube
Yes, I did vote for it and it is bc mcnally delivered a single port robot. I can’t believe that you are trying to deflect and defend bernholtz and what he and his cronies did. Good ole Marty “Sell shares and buy back more on the drop” bernholtz.
No apparently it was this guy Martin Bernholtz:
https://www.osc.gov.on.ca/documents/en/Proceedings-SET/set_20190516_bernholtzm.pdf
To some this is ok even though it was illegal.
So you are saying that what good ole Marty bernholtz did was less detrimental then what others did. WOW! I wouldn’t even compare what JH or RR did as anything g close to what bernholtz did. For goodness sake, the Canadian regulatory agency went after bernholtz for illegal activity. Can’t believe you could even justify what bernholtz did.
Well they certainly haven't done something as ILLEGAL as this:
Insider trading
stealing from other investors
Can't believe that you are defending the guy
Good ole Marty Berhnoltz,basically he was selling shares and then buying more shares at the lower price. You can just see marty telling people to sell and then buy back in later and get more shares. what a piece of sh.t. He’s as much responsible for the lack of market confidence in Titan as anyone who’s ever worked for them.
I can see ole Marty Bernholtz "hey this is what you do, sell your shares and then buy back in when it is lower and then you will own more shares" - what a sleaze bag.
Augmented Reality - Titan - Verb....smoking gun right there. Did Titan say something about Augmented Reality software capability?!!??! I missed that and IF THEY DID, only one company robotic surgery that i know of doing augmented reality is VERB Surgical.
Timesyours, that can't be....the only company right now that is even close to Augmented reality in surgical robotics is VERB Surgical. No one else is even close....
HoneycombHelen777 - did you know that as a foreign company Titan Medical must have a US Sponsor for their IDE APPLICATION - who do you think it is?
the Sponsor is different then the CRO
From FDA:
FDA regulations governing device clinical trials do not speak specifically to this issue, as you have noted. While FDA would indeed like to harmonize regulations regarding the conduct of clinical trials across FDA-regulated products, there are no present plans to amend 21 CFR Part 812 in this regard. In any case, for all FDA-regulated studies, the sponsor is ultimately responsible for the fulfillment of sponsor responsibilities, even though contracts confer regulatory obligations on CROs for pharmaceutical studies, as described at 21 CFR 312.52.
Presently, there are no regulations or guidance documents that delineate FDA's thinking with regard to the use of CROs for device studies. If issues with regard to sponsor responsibilities are discovered during bioresearch monitoring (BIMO) inspections of a device study, FDA holds the sponsor responsibility even if there is a contract in place for a 3rd party (CRO) to perform the particular aspects of the study in question. It is still legally wise to have such a contract in place which specifies in detail all aspects of the study to be contracted. However, lack of an adequately worded contract would not be cited in post-inspectional correspondence but instead what was found to be non-compliant would be discussed, with the sponsor held responsible even if it had been specifically contracted to a CRO. It is therefore prudent to audit the CRO before, during, and even after the completion of the study to ensure that they can and have fulfilled the responsibilities contracted to them in a manner satisfactory to the sponsor.
Foreign companies/studies
Can a foreign company submit an IDE/Is a U.S. Sponsor required?
A foreign company cannot sponsor an IDE; the company must have a U.S. agent who acts as the sponsor (see 21 CFR 812.18(a)). The U.S. agent must fulfill all the responsibilities of a sponsor identified in the IDE regulations.
Foreign companies/studies
Can a foreign company submit an IDE/Is a U.S. Sponsor required?
A foreign company cannot sponsor an IDE; the company must have a U.S. agent who acts as the sponsor (see 21 CFR 812.18(a)). The U.S. agent must fulfill all the responsibilities of a sponsor identified in the IDE regulations.
Name one.
Foreign companies/studies
Can a foreign company submit an IDE/Is a U.S. Sponsor required?
A foreign company cannot sponsor an IDE; the company must have a U.S. agent who acts as the sponsor (see 21 CFR 812.18(a)). The U.S. agent must fulfill all the responsibilities of a sponsor identified in the IDE regulations.
Responsibilities of Sponsors for Significant Risk Device Studies
General responsibilities (§812.40)
Sponsors are responsible for selecting qualified investigators and providing them with the information that they need to conduct the investigation properly. They must also ensure proper monitoring of the investigation and IRB review and approval, submit an IDE application to FDA for significant risk device studies, and inform the IRB and FDA promptly of any significant new information about the investigation.
FDA and IRB approval (§812.42)
A sponsor cannot begin an investigation or any part of an investigation until an IRB and FDA have both approved the application or supplemental application.
Selecting Investigators (§812.43)
A sponsor is responsible for selecting investigators qualified by training and experience to investigate the device.
Selecting Monitors (§812.43)
A sponsor must select monitors qualified by training and experience to monitor the investigational study in accordance with the IDE and other applicable FDA regulations.
Device Control (§812.43)
A sponsor can ship investigational devices only to qualified investigators participating in the investigation.
Investigator Agreements (§812.43)
A sponsor must obtain a signed agreement from each participating investigator that includes:
the investigator's curriculum vitae,
a statement of the investigator's relevant experience, including the dates, location, extent, and type of experience, where applicable,
an explanation of the circumstances that led to termination of a study if the investigator was involved in an investigation or other research that was terminated,
a statement of the investigator's commitment to:
conduct the investigation in accordance with the agreement, the investigational plan, the IDE and other applicable FDA regulations, and conditions of approval imposed by the reviewing IRB or FDA,
supervise all testing of the device involving human subjects. and
ensure that the requirements for obtaining informed consent are met.
sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement as required under 21 CFR 54, Financial Disclosure by Clinical Investigators. The sponsor shall also obtain a commitment from the clinical investigator to promptly update this information if any relevant changes occur during the course of the investigation and for one year following completion of the study. (The financial certification or disclosure is submitted in the PMA or Premarket Notification 510(k) application. It should not be submitted in the IDE application.)
Informing investigators (§ 812.45)
A sponsor must supply all investigators participating in the investigation with copies of the investigational plan and a report of prior investigations of the device.
Monitoring (§ 812.46)
Securing Compliance: A sponsor who discovers that an investigator is not complying with the signed agreement, the investigational plan, the IDE requirements, any other applicable FDA regulations, or any conditions of approval imposed by the reviewing IRB or FDA must promptly either secure compliance, or discontinue shipments of the device to the investigator and terminate the investigator's participation in the investigation. A sponsor must also require that the investigator dispose of or return the device, unless this action would jeopardize the rights, safety, or welfare of a subject.
Unanticipated Adverse Device Effects: The sponsor must immediately conduct an evaluation of any unanticipated adverse device effect. A sponsor who determines that an unanticipated adverse device effect presents an unreasonable risk to subjects must terminate all investigations or parts of the investigations presenting that risk as soon as possible. Termination must occur no later than 5 working days after the sponsor makes this determination and no later than 15 working days after the sponsor first received notice of the effect.
Resumption of Terminated Studies: For significant risk device investigations, a sponsor may not resume a terminated investigation without IRB and FDA approval. For a nonsignificant risk device investigation, a sponsor may not resume a terminated investigation without IRB approval. If the nonsignificant risk study was terminated for unanticipated adverse device effects, the sponsor must also obtain FDA approval.
Sponsor records (§ 812.140)
The sponsor must maintain accurate and complete records relating to the investigation. These records include:
all correspondence including required reports,
records of shipment of the device,
records of disposition of the device
signed investigator agreements including financial disclosure information,
records concerning complaints and adverse device effects whether anticipated or not,
any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigation or a particular investigation.
See Records for additional information on recordkeeping requirements.
Sponsor Reports (§812.150)
The sponsor must provide the following reports in a timely manner to FDA, the IRB's, and/or the investigators.
Unanticipated Adverse Device Effects
Withdrawal of IRB Approval
Withdrawal of FDA Approval
Current List of Investigators
Progress Reports
Recalls and Device Disposition
Final Report
Informed consent
Significant Risk Device Determination
Other Reports
See Reports for more information regarding required reports.
Labeling (§812.5)
Under §812.5 an investigational device or its immediate package must bear a label with the following information:
the name and place of business of the manufacturer, packer, or distributor;
the quantity of contents, if appropriate; and
the statement, "CAUTION Investigational device. Limited by Federal (or United States) law to investigational use."
The label must also describe all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions.
The labeling of an investigational device must not contain any false or misleading statements nor imply that the device is safe or effective for the purposes being investigated.
The sponsor should provide detailed information on device labeling in the investigational protocol. This information may vary depending on the device and the nature of the study. Product labeling should be sufficient to ensure stability of the test article for the duration of the study (storage requirements, calibration procedures), bear sufficient directions for proper administration, and detail procedures to follow in the event of patient injury.
Promotion of Investigational Devices (§812.7)
Under §812.7, a sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator cannot:
Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.
Commercialize an investigational device by charging the subjects or investigators a higher price than that necessary to recover costs of manufacture, research, development, and handling.
Unduly prolong an investigation. If data developed by the investigation indicate that premarket approval (PMA) cannot be justified, the sponsor must promptly terminate the investigation.
Represent that an investigational device is safe or effective.
However, the sponsor may advertise for research subjects to solicit their participation in a study. Appropriate advertising methods include but are not necessarily limited to: newspaper, radio, TV, bulletin boards, posters, and flyers that are intended for prospective subjects.
Advertisements should be reviewed and approved by the IRB to assure that they are not unduly coercive and does not promise a certainty of cure beyond what is outlined in the consent and the protocol. No claims should be made, either explicitly or implicitly, that the device is safe or effective for the purposes under investigation, or that the test article is known to be equivalent or superior to any other device.
FDA considers direct advertising for study subjects to be the start of the informed consent and subject selection process.
Additional guidance is available in the following guidance documents:
"Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators, 1998 - Recruiting for Study Subjects"
Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects
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Foreign companies/studies
Can a foreign company submit an IDE/Is a U.S. Sponsor required?
A foreign company cannot sponsor an IDE; the company must have a U.S. agent who acts as the sponsor (see 21 CFR 812.18(a)). The U.S. agent must fulfill all the responsibilities of a sponsor identified in the IDE regulations.
JnJ/Titan/Verb/Auris
Good luck w that
So u think this company is one of 2 things that Titan can announce that will move PPS. U might want to check the carbon monoxide monitor in ur house. I can’t see how this company being the partner would move the pps. If I believed this, I’d sell my entire position and get out of dodge.
Based of your post here, u state that these 2 things would effect PPS positively. I can’t believe u think that a Microline partner in end effectors would have the affect of moving PPS, therefore it would have to be a company like JNJ.
DO you really think that if they announce microline as the end effectors partner would drive Pps higher?
Honey, in your opinion is microline the current supplier of end effectors?
Told u
Boy, wonder which company posted tons of jobs after 2015 and hired a bunch of people to help build end effectors for a novel surgical robotic platform. Let me help the spoon people here- it was JNJ.
So based on your post you agree that the end effectors partner isn’t microline and the software partner is not Livedata.
So if it isn’t microline or livedata- who is it? What end effectors partner would want to keep it very quiet (jnj)?
Maybe this could be a scenario which the following convergence happens - reminder, just a wild guess here but one possible scenario is:
JnJ/Titan/Verb/Auris
Now I understand that is a little outside the box thinking but figured since it hasn't been shared on this board that some coming to this board might just find it an intriguing possibility. Maybe something worth digging into.
Again, all IMO but I figured that most people are posting about this tanking and over and done with (even though, I shall point out, they are still have money invested - go figure that one out), that it might be helpful to point out some wild, cockamamie theory that is possible. Heck some even said that a reverse merger with TRXC is possible so why not throw another one out like JnJ/Titan/Verb/Auris that could help those doing due diligence.
Honeycomb Helen - got a nice ring to it or would it be Helen Honeycomb, might as well just go with HH777.
End effector is JnJ
Software is Verb.
I love that Titan announces a partnership with Teleflex for a second generation clip but won't divulge the end effector partner (signed in 2015ish) and the software partner for this first generation robot. Also, on the rebranding - amazing that 4 people at Titan can't decide on rebranding so they need more time - what is that? We got bigger problems if they can't figure it out among the 4 of them. Last time i saw this type of indecision it usually involves one of the big boys like a jnj, medtronic, stryker.
The other thing is that software and/or provider of that software will have to be fda approved or at least signed off on by the FDA - what I will be looking for is some sort of FDA action on software supplier for medical device or robotic platform within the next 2-3 months - IMO that will be our software supplier
They are going it alone? If that is the case, sell it all. If Audio stream comes out and they indicate that - dump every share you have b/c this will be back at 20 cents in no time and the dilution will kill it all. Sell, Sell, Sell if they are going it alone and back to the well, well, well.
Same location as Plexus and Teleflex. JnJ has a presence in RTP, Google has a presence in the Triangle. Yes, TRXC is down there too, they might be the ones who occupy the space with the boarded up windows.
FYI, it’s 5 testing sites
Obviously, that's why you sold your position and bought warrants that expired worthless.
speaks to your "due diligence". would cross you off as having any credibility but did that way back....
Don't be an idiot, read the postings - how many of them work in surgical robotics. Go buy more warrants that expired.
I will share this one but along with it I'd like to make this point that just a little digging and a little effort anyone can find this:
https://www.indeed.com/q-Titan-Medical-Office-jobs.html?advn=1856892634269144&vjk=9b7b170efc39d98d
https://investorshub.advfn.com/Titan-medical-inc-TMD-31287/
Titan on a hiring spree:
Check out indeed.com
I also noticed that Virtual Incision has more employees than Titan Medical and they are so early on in R&D compared to Titan. Does it matter how many employees Titan has at this point? Is it any indicator as to when they will commercialize? Is it 12 months? 18 months? 2 years?
What about Auris that had over 200 employees prior to commericalization or TRXC that had well over 100. Auris went for $5.7B for a niche market and TRXC, who is targeting general abdominal surgery, can't even find a suitor. It will be very interesting how this all plays out.
https://investorshub.advfn.com/Titan-medical-inc-TMD-31287/