Member Info for Tyke68

So previously Semantic said rounded trades could be an indication of institutions buying the shares. All our buys today have been rounded. Coincidence?

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Who feels we know less today than we did yesterday?

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Another question

If somebody normally sells 28% of a company unexpectedly wouldn’t the share price collapse and in this case it hasn’t moved?

Still can’t get my head around why just one trade and not two? Ho can two independent parties sell in one transaction? BB you like investigating TB this might be one to add to the list.

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Mornington

We can but hope.

But what has KS done with her shares?

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Ok as somebody who hasn’t got a clue what is going on, my question is how can TB and FAB both sell their shares in one transaction if TB has supposedly nothing to do with FAB any more? Doesn’t that totally contradict this.

Also who has bought them?

Well let’s all try and enjoy the weekend before we find out what’s happening.

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Thanks Max

So under fast track you can get approval after phase 2. Is this what we are aiming for? I wonder how good the phase 1 results will be.

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Ok bear with me, it’s is possible we can get a drug approved by end of September 2026 to qualify for a voucher?

I initially said no way. However, establishing phase 2 protocols to be discussed this year according to the interim results. So we are being helped via fast track designation.

Do we need to do phase 3?

According to this then maybe no because we are an orphan drug

http://www.curonz.com/orphan.html#:~:text=With%20Orphan%20Drug%20Status%20it,a%20Phase%20II%2FIII%20trial.

Plus reading about the accelerated approval program, the surrogate endpoint marker mentions radiographic images, isn’t that what IB does?

Accelerated Approval Program | FDA

What is each phase?

https://www.fda.gov/patients/drug-development-process/step-3-clinical-research

How does EAP fit into it. We are getting real world data from outside the clinical trial. So does that alleviate some of the requirements of phase 3? Plus we are an orphan drug so we don’t need to be compared to any existing drug.

So earlier in the week I was very skeptical about us achieving drug approval in less than 24 months. However now, trying to tie everything together is it possible? If so Mike and the team are pulling off a minor miracle.

Of course all the above could be purely coincidental but I keep saying why have IB wasted time on getting all these designation? Would a PRDD voucher be icing on the cake.

If so then we can put TB back on our Christmas card list.

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Thanks Max

Not noticed it before hence my question. Let’s hope we get some good news in the shareholder letter.

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Thanks Max

I have a question if somebody could possibly answer please.

The EAP trial NCT06404034 says sponsored by IB but the GAM drug trial NCT04319276 says sponsored by MCW not IB. Why the difference, I thought we were the main sponsor of both?

Where does that place IB legally with relation to the GaM trial/ownership?

Thanks in advance

We can dream

Gee

I can’t see TB accepting less than the 20p he could have had before. Semantic implied this previously. Unfortunately we are just sat in the dark not knowing what is happening

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Sorry not trying to cause arguments but this is what I mean by IB have applied for all these designations but in this case is it worth it?

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We have the designation but how do we get FDA drug approval in less than 24 months?

We haven’t finished phase 1 yet so how can we complete 2 more phases in less time it took for phase 1

Unless we can use EAP and fast track maybe?

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The company currently has until September 2026 to get the drug approved to qualify for a voucher.

This seems highly unlikely when we haven’t even finished phase 1. Unless the EAP real world data can expedite the situation dramatically we will not be getting a voucher in my opinion.

So why did we apply for it, what does the company know that we haven’t been told yet? It seems strange the company mentioned the voucher previously if they knew it could never be achieved.

https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-designation-and-priority-review-voucher-programs#2024update

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Max

Reading it, it seems they want to achieve what IB have already achieved. We already have this capability.

So here’s a question why don’t GEHC just say we can already do some of this with IBs technology? Are they edging their bets and looking for an alternative to IB or maybe they will buy IB’s imaging side to integrate with this project.

Thanks for sharing and it does show the need for IBs technology. So why are we not selling it to everybody around the world already?

We need sales reps to be knocking on doors to get sales.

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Thinking about what Semantic said about valuations. Why would the company spend so much time applying to the FDA for the drug to be designated in so many ways; fast track, Orphan drug, Paediatric rate drug, EAP etc if they had not been greatly encouraged by what they have seen so far in the trial? Surely they would have spent more time on the imaging side and generating revenue that way.

IB are not doing the drug trial they are just sponsoring it. Mike and the team must truly believe in what they have seen so far to spend so much time applying for different designations. So semantic’s single figure multiples just doesn’t stack up in this case I would say.

Saying that hopefully we get some news on the imaging side as well in the shareholder letter; the insurance coding, Zero, Nimble etc. It would be nice to find out where we stand on all our products and how much revenue they are generating now and in the next couple of years. Have the sales inquiries turned into revenue if it was an easy upsell etc.

Anyway just my thoughts on another quiet day, probably. Patience and time required but unfortunately that is what we can lack at times by human nature.

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Semantic

Sorry forgot to ask what are your thoughts on the company spending money on professional videos ? How do you think they will help sales if they just put them on the website or YouTube? Is there something behind this we have all missed, where will they be used or distributed. Trade fairs maybe?

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Dear Semantic

I get the feeling you don’t do anything out of curiosity, everything is carefully planned. You and the board will have looked at these figures but we all know these figures could be totally irrelevant by either the imaging or drug side taking off.

But we have less than 11 months before TB self set deadline of himself being judged by the share price. I wonder what will TB do if the share price has gone down. Will he quit or take a reduction in salary, maybe he will forego his share options along with the rest of the board.

Have a good rest of the weekend

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Gamflin have we got FDA approval for Zero yet? I thought we were waiting to resubmit the massive amount of data required. I agree when/if it could be a major revenue stream but the company has gone quiet about it recently. Apologies if it has been approved and I have missed it.

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Gee

Enjoy the the break

Just looking for this video on the IB website and I couldn’t find it but I could find another professionally produced one on nimble. They seem to be pushing Nimble but hopefully not by just putting these videos on the website or YouTube.

Let’s see if the letter is just slipped out by tweet this weekend or next then we really need to ask the question what is happening.

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