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I am not sure. I did not do the digging. I am just commenting on the statement in the filing. The idea of the PMA route is not new.
Then why is a PMA being discussed?
Certainly hope so but it's not a given.
Just for the record...
All devices are classified per risk (I, II, or III) per FDA CFRs. PMAs are mandatory for Class III devices:
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing approval. Please note that some Class III preamendment devices may require a Class III 510(k).
PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).
He was the head cheerleader until his departure.
Please HC, ISRG did not pay off the FDA.
The SPORT technology was always subject to a PMA. I brought this possibility up way back in 2014 -2015 and Lefty laughed it off.
https://www.fda.gov/about-fda/cdrh-transparency/overview-medical-device-classification-and-reclassification
https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma
https://www.fda.gov/medical-devices/products-and-medical-procedures/device-approvals-denials-and-clearances
Has anyone posted this yet? Thoughts?
https://www.nippon.com/en/news/yjj2020081101024/
No. It is apparent that Medtronic mistakenly jumped the gun with Hugo.
I think for 66 to surmise that Medtronic has since moved on and Titan's work will become Medtronic's future is logical.
I concur!
Good logical post. Thanks 66!!
LoL at Rapture!
LoL.
Gotta LOVE the noise!!!!
Damn you TMDI...
<shakes fist>
Honeycomb the Socialist is entitled!
Lol Timteo.
Yes, I agree. Let's lower the buyout target so HC doesn't feel jipped when the engineers exercise their options.
What the hell planet am I on?
Seriously Small Noz, why do you beat yourself up over these hypothetical numbers? No, I'm not happy they diluted again. But I'm not gonna lose sleep over who is gonna get what slice of the pie. Corporations are gonna take care of the people they want to take care of. That's how it works. You sound like a socialist. If it bothers you so much, go apply for the janitorial gig at the new NC facility.
They still implementing the "Blue Ocean Strategy" over at Verb?
Oh that Rory, he certainly loves his Stakeholders!!
Hope so!
Told you not to get too excited just yet Liv! You are not a very good listener. Let's see how it plays out a little before we start talk'n 'bout $5+ bil buyouts. You went from "McNally is a disaster to McNally can do no wrong" overnight. Don't get me wrong, I love the new relationship with MDT. Just not convinced WE, the shareholders, matter much. Just a reminder, Titan has not been kind to shareholders... EVER!
Exactly how I feel. If you've been around long enough and have been forced to buy "defensively," the mere thought of continued dilution will make you vomit. My initial buys in this were based on old timelines set back in 2014. Like Belize, I've had to keep buying to stay in the game because of poor execution on the part of management. Not only was there ZERO advantage in being early to this, it was a huge NEGATIVE.
I agree.
As long as we are invested we STILL need to hold Titan mgt accountable. We only know what we have been told and what we have read. There are still no guarantees. Hell yes I feel better about this project with MDT involved. But I AM NOT willing to just assume all things are rosy all the time and put my head in the sand. We are below $1 again. We just got diluted again. Mgt has rewarded themselves again. We don't have a planned AGM. We don't have a Milestone Timeline. These are things that should at least cause an investor to and say "Why?"
Good post. It's been said over and over again here on iHub - It's all in the patents!
Per the statement in bold, jointly developed IP is Medtronic's property. Per item a) Each party owns it's own, solely developed IP.
Very old news.
Were they kissing or jumping? Or both?
Thanks for that suggestion BeeHaus! Wish I had bought a ton more. That is a great ticker!
Hey Liv...ur smart.
LMAO! I took it in the arse on Rory's BS too. Sold at ~$25k loss. Will make it up and then some with Titan so not too worried. Plus that POS Verb gives me a much-needed write-off for the next 8+ years.
TOMORROW is the last day to register for the World Robotics Virtual Conference for free. After tomorrow, it's $100.
https://sors.memberclicks.net/2020-virtual-annual-meeting-form#/
AGREE!
Solid post and great info 66. Thanks!
Lol I am/was linked with Nahon and Shore on LinkedIn. WTH happened with those two?
Lol. Yep. I remember how it literally drove you insane.
Bring back Reiza!!!!!
True.
No argument. I definitely don't like his current negativity and his attempts to benefit himself by swaying new investors.
It's funny how so many people pat themselves on the back when they think they are right and disappear when they find out they are wrong.
Bottom line, I appreciate when people are able to share good, concrete information - with source documentation - on this board, whether it is positive or negative. All the self-promotion after-the-fact is just noise!
Agree. 19 is jaded. Cannot blame him one bit.
I will gladly sh1t my pants on Buyout Day!