Member Info for Irishboy

Https://www.investormeetcompany.com/meetings/fina

A recording should soon be available for those that missed it

9-30 we going live to TSP meeting

Nice to see TSP have joined the 21st century and set up an online meeting , if you have any questions you can post them on meeting website and all will be answered 🤦‍♀️

With our full year results due out at the end of this month,(September)

This is the only thing that is happening with TSP!

There is zero attempt at FDA or anything else , so there’s no wonder the SP is only going in one direction (down).

At least LS did get it to rise a little bit for short period , but then Viagra wore off and GM took over !🤡

And that’s overpriced 🤦‍♀️

So it’s not over 400days and counting ,for FDA 🤔.

This is from the company that TSP employed , so don’t let it be said that it’s nothing something TSP know or knew about .

FDA have given up on TSP and vice versa .

The end of year results are due at end of month , be interesting 🤔 is this when TSP is wounded up ?

Or are we going to be taken over by Zimmer Biomet ?

Https://www.emergobyul.com/news/how-long-fda-review-process-510k-medical-device-submissions

March 6, 2022

Medical device manufacturers submitting 510(k) applications to the US Food and Drug Administration typically have questions regarding review timelines and communication channels as they await clearance decisions from the regulator.

FDA has provided details addressing such questions on its 510(k) premarket notification webpage that summarized typical communications between agency reviewers and medical device applicants between submission and final clearance. FDA’s 510(k) webpage now also reflects the timeline that medical device and in vitro diagnostic (IVD) device manufacturers can currently expect when submitting registration applications to the agency.

Medical device manufacturers submitting 510(k) applications to the US Food and Drug Administration

The FDA originally published its chart to meet 510(k) performance goals set up by the Medical Device User Fee Amendments of 2012 (MDUFA III). The chart indicates a 90-day timeframe for most 510(k) clearance decisions and spells out what manufacturers can expect in terms of possible communications with FDA reviewers during their US medical device registration process.

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

Prior to MDUFA III, medical device industry advocates had complained about unpredictable and inconsistent requests for additional information and other communications from the FDA causing US registration delays. Although this new chart is just a chart and not a track record of FDA review performance, it does provide a much clearer picture of what 510(k) applicants can expect from the US regulator once their registrations get underway.

There’s no need for Miller to do anything .

He’s already said no running commentary on FDA .

And no influx of money until June 2025.

So radio silence for 10 months from TSP.

Dcode contact me

obella at live dot com

About TSP

Dcode, contact me , obella at live dot com

Dcode you asked before for contact , you can contact me at

obella at live dot com . I would like to hear your story .

Sorry I thought you might be man enough to at least give initials, especially seeing that you state you have no connection to TSP now or in past .

So what are you hiding ?

Are you on the same IQ level has sleepy Joe Biden?

It’s just strange that you keep popping back on here using new names , posting a few and then disappearing until rise like a phoenix.

Sorry Dazzler but I think he’s already been a member of group and was booted out . Maybe you have him in your group , we are very selective , no riff raff .

If he wants to reveal his real identity I’m sure he’s big enough to put his initials on here . Not that it really matters , we know their all linked to crooks .

Get a grip , it’s bloody obvious who you are , an American inventor who is trying to convince the new BoD that cervi-lok is still possible if they can raise the money to pay off all outstanding debts and also keep your male lover in Florida on payroll .

So jog on old lad and take your fantasies with you xxxx

Going by the time this new poster ,posted presuming he is on Eastern time in America .

The amount of garbage he is spouting is typical of an inventor and x convict .

I presume the meeting went well with GM and ex sales rep the other week in USA .

Come up with more BS to feed the market with .

The company is dead ! FDA for cervi-lok is dead .And what with all these supposedly legal action being taken by shareholders according to certain posters , surely you will all end up with no money and long sentences in prison 🤦‍♀️

Without the £1.5 million investment that was supposed to be shortly coming (stated in AGM) is FDA now off ? Seeing that there’s no money to pay for anything is the company now just an empty hope ?

if the FDA have issued updates from when TSP applied back in July 2023 isn’t it fair to publish these responses for shareholders to understand what the hold up is .

Geoff s reply ,

Where we stand with the FDA process is that it is ongoing. The reality is that any regulatory process is always of indeterminant length, and any attempt to predict what a regulator may or may not do risks being self-defeating, because regulators hate to be second-guessed. I have been around regulated businesses now for almost 40 years, and the golden rule of working within any regulatory regime is never try to pre-empt a regulatory decision. Therefore we will not be trying to lay out a time frame or make any commitments on regulatory approvals.

What a load of sh**

Https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process

Shouldn’t take over a year for FDA then ?

Does that mean there’s no £1.5million investment coming Geoff until at least June 2025 ?

Oh well another AGM before then surely ?

Keep up the good work TSP , you’ve really turned things around in the last several months , company is unrecognisable 🥳