Member Info for Tyke68

We had a shareholder letter update in January last year, I wonder if we will get another this year?

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Let’s see if Mike has an update for us when America is awake

Happy New Year everyone

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Geoforce

That article was released 24 June 2021 in the applied radiology journal and Mike’s comment were from June 2021 as well so I wouldn’t read anything into this being a new press release. I think what may of happened is when you search the journal it comes up with today’s date not the date of when it was published. I believe this is an old press release not a new one

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Fingers crossed this is just the beginning. Two nice blue days wasn’t what I was expecting this week but great news.

Have a good New Year everybody

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The comment from Mike was from June 2021

https://www.imagingbiometrics.com/wpib/wp-content/uploads/2022/03/2021-06-IB-Awarded-Patent-IB-Zero-G.pdf

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Strange to get coverage today when the patent was awarded in June 2021

Something happening with it finally maybe?

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Are we one of the few companies where the long term holders are desperate for a TR1 to say a major shareholder Jase reduced their holding?

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Yet more info on the voucher process

This seems to be an update from last week. So we need to get the drug status by September 24 then claim the voucher by September 26, still not sure if we need to get drug approval to get the voucher but seen as we are now being fast tracked it gives us a final deadline of sept 26 to get the drug approved by. That seems very quick to get phase 2 and 3 completed.

“RPD Designation Program Sunset Provisions

On December 27, 2020, the Rare Pediatric Disease Priority Review Voucher Program was extended. Under the current statutory sunset provisions, after September 30, 2024, FDA may only award a voucher for an approved rare pediatric disease product application if the sponsor has rare pediatric disease designation for the drug, and that designation was granted by September 30, 2024. After September 30, 2026, FDA may not award any rare pediatric disease priority review vouchers.

For any questions, please contact the Office of Orphan Products Development at orphan@fda.hhs.gov.”

Let’s see what update we get from Mike if we get PRD designation next month.

Have a great new year everybody

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No news and quite a few shares purchased this lunch

Let’s wait and see

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What’s the likelihood we get a TR1 or two in the next week or so?

Then things may get exciting quickly

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Merry Christmas everybody

I hope you all have a great time (not checking Sp’s etc)

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BRH bought some shares for £8 in August and have just stated they are considering selling for £17.74. TB definitely making a profit on those shares.

Is he selling up and thinking of retirement?

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This is an informative article about when you can apply for the PR voucher by a company that has been designated as a rare paediatric drug. The part just under the highlighted section seems to imply it will be many years before we can get a PRV ie after we have applied for it to accepted as a new drug.

https://laminarpharma.com/laminar-pharma-receives-rare-pediatric-disease-designation-from-the-u-s-fda-for-lam561/#:~:text=RPD%20Designation%20is%20granted%20by,than%2018%20years%20of%20age.

However, this contradicts the all process (rare paediatric drug designation) is due to be stopped (next year) I believe

The more you dig the more confusing this situation becomes.

Let’s hope Mike is fully conversant with it.

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A few nice buys today but not much else happening apart from the sp falling obviously. Interestingly I could only sell £300 with HL but no more than. No intention of selling but thought I would have a quick look to see the current price.

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Cautious

I don’t think people have different agendas I just think applications are more tangible to people. I was the one who first said the voucher maybe a long term off. We honestly don’t know what is going to happen next year but it should be exciting for the drug application and imaging, hopefully we get an update on IB zero as well

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TB only controls 30% of the company so I can’t see the other 70% of shareholders accepting a low takeover bid

PRV seem to average $100m so that would be the starting price for a takeover in my opinion

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A bit of profit taking this morning

Hopefully it will soon change blue

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Let’s see how the market reacts today. Knowing our luck there will be a RNS saying FAB have reduced their holding and the market will react negatively regardless of what this will mean for the CLNs.

Fingers crossed we keep the upward trend

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Evening

Regarding the voucher I could be mistaken but it is not intended for the product you are claiming for. It is to prioritise another product. Hence able to sell it to a different company. Again as Trek says it is very unclear and we just need to wait and see what happens.

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Hopefully PRD approval next then apply for the voucher.

Well done to all the team

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