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Ann: Webinar Presentation - Phase IIb study of avicursen, page-28

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itsagas

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07/02/25

16:55

Post #: 77758644
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Originally posted by samfiodiving: ↑

I watched the webinar late last night

it was very clever how they put it together
in their use of Cathryn

They would be aware that Cathryn s appointment was well received by most holders

And in light of the recent vote at the AGM one could say that there are a number of SH that just do not believe in the CEO anymore, Myself being one, but in saying that I am not in favour of the challenge group either and have voted accordingly.

So back to the Webinar as I said very clever how they went through the presentation Basically a Q and A from the webinar where James was putting most of the onus not all but most on Cathryn to present the Outcome and reasons why.

Cathryn did a very good job of how she portrayed the outcomes with her answers, and I suppose it carried more weight trust wise than any other member of the board could have done at this moment in time

We can understand now that the use by date on the drug was not an issue as the results in the reduction in CD49d did show up in the data so obviously the drug was working as it should

I accept that that the Pul2.0 a physical test laid out as the trial standard also failed

But then we moved onto the Q an A by shareholders

For me this is where in my opinion, Cathryn dropped short in her reply, in favour of the company on one particular question.

The question put forwards was on why was MRI not used and Cathryn gave her answer in line with the companies position that they did not include MRI in our Trialfor reasons given

This I have contested previously and believe it was a massive oversight to leave this vital part of the puzzle out of the trial

Yes we failed the physical part of the trial yes I accept this

But in our 2A we showed a reduction in our target marker being CD49d no we didn’t hit target but we found we did reduce numbers

Then we drilled down further through the use of MRI to show that both muscle mass and fat fraction had actually either made slight improvement in muscle mass or stabilized and reduced the fat fraction normally seen in these boys.

This I believe was a big part of why we moved into the 2b

I remember as well as anyone Prof Voight saying, these were results that had never been seen before in DMD, which was a massive selling point on my behalf anyway in moving forwards

I remember him also saying like Cathryn who backed in his words saying it was
difficult to carry out this operation with regards to this and that.

But I put this out there did we not just do a trial with 9 boys in our 2A and each and every one of them went through the MRI process,

a process that he himself took as witnessing something in these boys that had never been seen before

SO WHY WAS IT LEFT OUT ?????? WHY

Not for the reasoning given that is for sure it may have been their opinions but it was not a fact

and that can be backed in by fact

So even though we failed the pul 2.0 the Physical side of things

Did we actually give our drug the best shot at success

personally by leaving out MRI I do not believe so why

well you all saw the results that Cathryn explained with ref to our target marker being CD49

CD49dweek 22

Placebo up +18%

25mg Held CD49d level planing

but in actual fact

It was a reduction of - 18% against Placebo

Then we look at the 50mg dosing

50mg dosing - 17%

Which in actual fact was

- 35% reduction against the placebo result

So yes we have shown our drug when hitting its target does have effect

But effect on what apart from its target we have no idea

Physically yes we were a failure but biologically did we have any effect had they set
up the MRI as a secondary biomarker

We could have seen drug V Placebo reduction in cd49d was there any difference between these boys at muscle level viewed through the process of MRI

Did our drug actualy halt the disease progression ?

did we stop the deterioration of muscle mass was fat fraction reduced in any way ?

These are questions we will never know Will our drug be thrown out through lack of MRI and confirmation of some form of method of action in at least halting disease progression at muscle level

yes I understand all boys deteriorated at more or less all same physical level Pul 2.0 shows this,

but these boys have moved into loss of ambulation they are at a very delicate stage physically

the big question is internally at a biological level did our reduction at a minus - 35% in numbers of CD49d apart from showing that clinical result alone, did we have any further effect biologically
ie in the stabilization of these boys at muscle level or any form of change even for the worse

This is something we will never know

WHY

because management in their wisdom decided for whatever reason to omit MRI from our trial

I have been here for a substantial number of years now and always maintained that the drug has never let me down it has always been management that let me down

I have accepted the failure YES

but have I accepted the drug was a failure in its own right,
well without giving our drug every opportunity it deserved to back up its previous results no im not convinced it was a COMPLETE failure due to lack of confirmation through MRI either way

I am still a holder here untill when I have no idea at this moment in time

I believe everything is done for a reason

Like the omition of the MRI it was left out for a reason

What was that reason

The reaons given I do not believe substantiate its leaving out especially when it was such a vital part of our original reason for moving forwards anyway

What I am trying to get across here is yes Cathryn was very convincing

But we are all here today some with huge losses and moved on, some still here showing losses maybe not as huge as some other but still showing losses

But we are all here because we believed what we were told

Did any of these people lie no way,

am I accusing of Cathryn of lying no way, what she delivered ref to MRI is what she thought was correct and backed her colleagues in

But I beg to differ and challenge the reasoning s given

But what I am trying to get across is just because these people may come from the highest level in their roles as professionals in their field, do not believe all you are told choose how convincing they may appear to be.

do your own research and if you feel you are correct put out the challenge and ask the questions and seek answers do not take things as gospel, because as we all know it can finish up being very very costly and believe me I have learnt the hard way many a time lol

I know that management read these columns so in light of this recent webinar where some questions get answered and some don’t

I would like to invite anyone from the per board to come hear on HC and answer for all to see not just a one on one where replies get hidden in single conversation

Please step up in the name of transparency and give true reasoning why MRI was not put into this trial

as it was in the recent Duvyzat trial

and got their ambulant boys with three times the numbers of our trial over the line with multi country clinics around the world
And received accelerated approval by using MRI as a secondary endpoint set up as a bio marker

Plus they have an ongoing trial in none ambulant again with three times the numbers in our trial throughout multiple countries

and as the UHF have advised they are doing ongoing trials in none ambulant boys with DMD using MRI

If you are not willing to come here and be transparent then i will be more than happy to eml a copy of this to you to put on your presentation at the AGM and please go through and give reasoning for all to hear

I am no professional if I have made error on any clinical information posted then I will apologize if the need is warranted, for my lack of knowledge.
But if I am correct then as a shareholder being put in the position I would like you as a board to repay that courtesy and apologies to all shareholders for your mistake by not including this in our trial and giving your shareholders the best shot at success

I don’t want a load of excuses either as I have had previous when I have challenged the board for what I believe not to be in the best interest of your shareholders

If anyone does try to spam this off the page then I will just re-post it

I will not be at the EGM

I voted in support of Charmaine only to stay on

Personally she is the only one I feel is worthy of the job and I understand if you do not want to come onto social media platform thats fine

this is not put up as a slagging/abusing contest online

this is the concern of a very long term SH that has supported this company over a very long journey to eventual failure

I believe you owe not only myself an explanation on this, but all shareholders should be included in the answer hence this post

Thank you

Sam

Expand

Nothing wrong with the science.
But very often a non controlled single centre study doesn’t predict success in a bigger multi centre study.
The latter removes bias. That’s why it’s too risky to go from a tiny phase 2a to a phase 3.
I believe the drug did reduce fat in muscle on the MRI in the phase 2a which was very interesting but unfortunately that change doesn’t translate into a clinical change.
FDA don’t accept the MRI changes as a surrogate for efficacy because they have yet to see the two linked.

Thanks for your input Sam.

PER Price at posting: 0.7¢ Sentiment: None Disclosure: Held
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