Member Info for stu485

Mr I,

HH has claimed (incorrectly) that the Complete Response has been issued and as such CH will be lifted or CR rejected, latest mid October( 30 day FDA window).

Why is this so hard !!

Hemo’ now have a plan to execute involving further testing prior to submission of their complete response to the FDA.

Should they execute that plan all as their proposal , then within 30 days of submittal date , CH will be lifted and H Car-T cleared.

No timeline has been offered for anticipated completion of the necessary works, only that they will be carried out expeditiously.

Factually, CR could be submitted anytime following the completion of the works described within the RNS and 1year from CH.

That’s it…get it or do i need to get the crayons out !?

AIMO

HT,

I agree !

The issue is, it’s a very important point.

If it were as HH claims in less than 30 days CH should be lifted .

Let’s see who’s correct !

Goodbye.

AIMO

HH,

Please stop !

If it was a complete response then the company simply awaits the FDA decision within a 30day period .

That’s not the case!

They are working on the fix as stated within the RNS.

It was not their CR !

Hopefully you’ll take a breath, consider the facts and understand. I know you’re intelligent and will get it sooner or later.

AIMO

Mr I,

I’m not in a battle and sorry you feel that’s what it is.

I will though correct those who misinterpret the facts, either deliberately knowing or through ignorance.

True, i was expecting some news for a push to Tranche 1 SP , and that hasn’t happened…yet !

AIMO

HH,

Please stop with the fiction !

The company have NOT submitted a complete response as you claim.

The company have advised within the RNS that the FDA are satisfied with their “Plan” to resolve.

The plan now has to be executed inclusive further testing.*

Upon completion the company will THEN submit their complete response and FDA then review for adherence to the plan prior to clearing with lift of CH.

No more stories today please, don’t have time to correct!

* Preliminary testing as mentioned within RNS , determines final testing for approval to follow.

AIMO

Digitt,

So your answer to why no timeline is;

it’s not within the company’s control as third party testing required and the FDA will use up unknown time to respond!

1. Testing is required or else there would be no ref to “preliminary testing “ within the RNS. The company know how long it’s taken previously, so it is not the unknown you suggest it to be.

2. The FDA are not required to comment again until resubmission, so no time element there !

You’ve not answered the simple question I posed.

AIMO

No more response today as other stuff to do.

Bline,

I have ! ..I thought a bigger bump in SP.

Seems the market has understood what many here have not.

It’s a step forward on a path that’s now clearly defined.

How long the path and the cost to reach the end, unknown.

Thumbs up to the company for at least communicating progress.

AIMO

HH,

That’s the most blatant and inaccurate post I’ve ever seen of yours!

I will only state the FACTS within the RNS.

The company has a plan that’s now been accepted by the FDA. Should that plan be executed as proposed, then CH should be lifted.

There’s no timeline on when and there’s no guarantee the plan will be executed to FDA satisfaction.

Therefore to state CH is effectively lifted is utter rubbish!

AIMO

Digitt,

Ask yourself a very simple question.

Q. Would the company offer a timeline to resubmission if they knew it to be short?

Of course they would ,so why not !?

If any ones at it again, it’s you !

AIMO

Micky,

The good news, i think a good bump to SP today and if so I’ll be happy for the LTH’s.

The bad news , clearly it’s not the lift of CH many had predicted.

The fix required is significant where many had claimed it trivial.

There’s no timeline on resubmission and by way of note on “preliminary testing”, there’s more required.

In summary, the company has a plan to fix that the FDA accepts. Unfortunately that’s it !

SP bump and placing to fund the works.

I hope for LTH’s i’m wrong.

AIMO

Should get a good rise on this as most won’t read it properly and comprehend the actual progress.

The RNS I predicted, the date I predicted and hopefully…goodbye.

No timeline to resubmission and further testing required.

Good luck all

AIMO

HH,

I’m sorry I strongly disagree.

The “single” issue you try to trivialise, some believe a fundamental problem that could involve very significant work, time & money to resolve.

The point being, it’s the seriousness of the issue and not the number !

AIMO

HH,

You sure that’s not 95% !!!!!

1. You don’t know what % has been accepted, so you’re statements false.

2. It’s not addressed until FDA considers it so, again a false statement.

JFH,

Dolphins can hold their breath for longer 😉

AIMO

HH,

Facts, Facts …Facts !

Nothing wrong in ignoring them if you wish, and nothing wrong in highlighting them either .

What is wrong is trying to convince others any reported fact that doesn’t fit your agenda is FUD .

I’m looking forward to more from HW as it seems, finally we have a properly qualified poster with valuable insight.

AIMO

HW,

Just catching up on posts and see your note to Pumpky.

I’m sorry but it did fail and Pumpky was correct .

It failed in its present form to CLEAR with the FDA.

We know it’s under CH until changes are made and supporting information provided that the FDA subsequently determines acceptable and as such, the IND application has not yet failed in its entirety and may not.

AIMO

121,

Let’s see what HW has to say in response.

I’m very aware of CRISPR editing pros/cons .

HW,

Given your background i’m sure your aware many are expecting the FDA to give the green light on a CRISPR gene edit treatment for SCD blood disorder in December this year !?

I wouldn’t disagree, CRISPR editing is more complex , newer and more scientifically advanced and as such , getting through the approval processes more involved.

Just think your timelines out… considerably!

Separate to the above(Vertex/Crispr), a more relevant CRISPR gene edit IND for AML treatment due this year (Caribu) !

Not sure how your comment below fits with the above ?

“Long answer is that this will take years/ decades to come into clinical use as it is essentially gene editing”

AIMO

Digittt,

“So I'll take the DOD's view so far that this is a potential microsoft of viral treatments over yours, thanks.”

Anytime you’d like to corroborate your words above would be great for all to witness.

It’s ok to get a little riled and immature when you’re questioned and don’t have an answer . We all make the same mistake on occasion, so no offence taken.

Good luck.

AIMO

JFH,

My position hasn’t changed.

Looking forward to Digitt substantiating his claim with the DOD written confirmation requested !

AIMO

Digitt,

Just for interest of the board , would you mind posting the DOD’s written confirmation that CBR’s the potential Microsoft of viral treatments, as you’ve claimed ? …only I can’t find it or any other third party independent reference concluding the same !!!

AIMO