Member Info for Tyke68

FAB sells them at the current sp then TB buys them back at the much cheaper price. If I remember correctly £300k+ profit from the last lot traded.

If he is going to convert his remaining CLNs will he do it before after we get the FDA updates? I believe somebody stated Boxing Day is the 60th day. But he is up to 60 days so I suppose it could be any day from now onwards.

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Isn’t this just a case of an endowment attached to MCW giving money to a MCW attached project? Is it to keep the research moving forward until we get a bigger grant from elsewhere?

I stand to be corrected

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TB gained over £300k of shares for £100k. Not a bad day, will he repeat it with the other CLNs.

Is KS the big loser as her 5% holding will now have shrunk?The website hasn’t been updated yet which is bit strange as when previous were announced it changed that afternoon.

IB team done the work but for a now reduced percentage in the company. He needs to keep IB team happy for all their hard work.

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But it also means no share buyback as that would take TB over 30%.

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Noluplus

Thank you for saying a long road to getting the voucher. I was beginning to think it was me against the rest of the board. Even though I hope I am wrong

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Red

Thanks for the comment, yes I did read the link as I commented upon it.

If anybody could answer this question with evidence I would gladly say my pessimism is wrong. “When, which month, do we expect the company to be in receipt of the PRV (the voucher which could be worth $100m+) ?”

Thanks, have a good day

For reference, Mike has not answered that question either.

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Cautious

Thanks, I was hoping for PRV not PRD news. Hence a bit more questioning (my own comments included) and further research. PRD, PRV, ODD etc all can get a bit confusing as to what means what.

I think the comment about distinguishing between IB and IQAI is valid. IB are doing all the work and I would like to see the IQAI BOD pushing their brilliant work to others.

Don’t worry not over invested and been invested for quite a while now and after seeing how much the Taycan drops in value I won’t be preordering anything especially a Porsche.

I just like clarity so we all know what is happening moving forward even if it means questioning my original thoughts. I don’t mind admitting if I am wrong as it can happen often.

Fingers crossed my pessimism is unfounded.

Many thanks.

Kane thanks for this. It is the use of the words qualify and eligible worry me. If you look at Trek’s reply “We request the voucher when we submit a rare pediatric disease product application – either in the initial package sent or up until the point of NDA/BLA filing. “ this makes me think it could be after phase 3 and we make our final submission.

The phrase initial package, is that for final approval or possibly when we started this process several years back.

Sorry for being pedantic, I hope it is in 60 days but if it is in final submission then we have to pass phase 2 and 3 to access the voucher and that increases the risk of ever seeing the voucher.

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Kane

No problem, it is a bit confusing. It is good we have these friendly discussions on this board as somebody stated earlier. Long may this continue.

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Kane

Thanks for this. All I want clarification of is when can we apply for the voucher. Is it after PRD designation or after we apply for approval of the drug with the FDA.

One would be soon next year, one would be quite a few years in the future.

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Kane/geoforce

Thanks for these posts but reading the flowchart and the sunset provision I still think it is unclear when you get the PRV. Is it we can ask for it in 60 days if approved or after we get the actual drug approved?

We have applied for designation and must be done by 2024 so that is ok

The PRV does not appear to be issued to be used with the initial PRD drug

The sunset provision also mention 2026 and Maximillion’s link states

“Under this program, a sponsor who receives an approval for a drug or biologic for a "rare pediatric disease" may qualify for a voucher that can be redeemed to receive a priority review ”

So it states approved drug, the keyword being approved.

Sorry not trying to be argumentative but we need a definitive answer from the company if the they get PRD approved at what point in the future (days/months/years) before they apply for the voucher.

If it is when the FDA approves the drug then we have to clear phase 2 and phase 3 first but the fast track application would help with this.

I would love to be proved totally wrong with my doubts, hopefully Trek gets the answer from Mike and I am wrong

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Joeblog

I assumed that as well but it is the word eligible that concerns me. Hence the more research. Are we only eligible if we get the drug approved as per section 529? All a bit confusing.

We could do with a timeline of what is happening when from the company just to clear up all ambiguity

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Trying to do some research and came across this on FDA website

“Under section 529 of the FD&C Act, a sponsor who receives an approval for a drug or biological product to treat or prevent a rare pediatric disease (as defined by statute) may, if the statutory criteria are met, qualify for a voucher that can be used to receive a priority review for a subsequent marketing application for a different product.”

Does that mean the drug has to be fully approved before we get the PRV? In which case we will not have the chance to get a voucher until the phase 3 has been completed, many years away? Let’s see what Trek hears back from Mike. Are we jumping to far ahead thinking 60 days when it could be more like 6 years?

You be step forward two steps back who knows? It would be far easier if some big pharma bought the company and paid for all the funding etc.

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Geoforce

Hopefully within 60 days we will know if we are eligible for a $100m voucher.

So we could all have a very nice new year’s present.

Fingers crossed.

Now if we only had a CEO who along with the board could market and advertise this and other ground breaking achievements to a wider audience. Or maybe he already has and just hasn’t told us of the deal he is planning. In which case we could have a very nice Christmas present heading our way. A Christmas gift from TB to all shareholders. Now that would be exciting.

So if we get fast track approval then RPD designation and the subsequent PRV what price would TB accept for the clinic trial side? And what price for the Imaging side of the company?

Would the company be worth £100m+ or is that just wishful thinking. I have literally no idea how much the company as a whole would be valued, 10s or 100s of millions of pounds. Let’s hope we get the chance to find out.

Well done to Mike and all his team and the medical staff as well.

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Reading the RNS again

“If IB's application is successful, the PRD designation provides incentives including eligibility for a priority review voucher that can be redeemed for a subsequent marketing application. This voucher can be used to reduce the time of an FDA new drug approval review or could be transferred (sold) to another company.”

It seems if we get the PRD designation then we are eligible for the voucher. So if we get the designation (in 60 days or less) then we can ask for the voucher. So it seems you have to get the designation first then you can ask for a voucher, not sure how long that takes but within 60 days we will know if we are entitled to the voucher we can sell at a later date. Sounds very positive to me. Let’s hope the market continues to view it that way.

Good luck everyone

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Maximillion

I was wondering that as well. The instructions seem a bit unclear. Hopefully the voucher is automatically awarded.

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A thought

TB said he was going to increase the value of the shares. IB keep posting all these positive notices but what has IQAI done to increase the value of the shares?

I think we should start distinguishing between IB and IQAI.

IB fantastic work

IQAI nothing of note except FAB have sold some shares, whatever happened to the share buyback? The BODs of IQAI maybe need to stop hiding behind the success of IB and start showing what they are doing.

Anyway just a thought.

Have a good day

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Dear Howdlep

You say we are not getting a bad RNS but you could also say we are not getting a good RNS soon or why would TB sell if he knew a financial windfall just around the corner?

We honestly don’t know what is happening with the shares so I for one am is just focussing on IB as a company.

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It doesn’t matter what TB and his family does with their shares/CLNs. They will only influence the sp short term. We should be looking at the bigger picture of what the company can achieve. TB is only trying to maximise his profit which all of us are striving for as well, we will all benefit in the long term.

The fundamentals haven’t changed, hopefully the next RNS is about the PRV.

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We just need to watch for a RNS or a tweet saying we have submitted the PRV application. Then it will be a 60 day countdown to see a truer share price for this company. No way we can still be at this mcap is we have a PRV which could be worth $100m+ plus hopefully fast track approval. Unfortunately, at the moment, all the positive news we get is fantastic for patients but is not having a positive effect on the sp. Better that way I would say, patients come first and we do seem to have the FDA guiding us forward as per ODD help.

Then if we hear about other possible grants/funding streams (Gates foundation been mentioned previously on this board) then time to start looking at where the mcap could end up.

Good luck everyone, just a bit more patience required. New year equals possible new car, holiday etc if all goes well.

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