Member Info for stu485

Hulver,

I'm not sure about Haywire (blocked for twisted science chat) but no answer form HemoKnowledge ( the man!) on the timelines for completion of FDA review of G-rex change and employment in patient treatment...I wonder why not !?

Even Kingpin in his alleged direct line to the company alluded to the process being in action when he slipped up and posted with reference to P3 delay;

"They have to meet certain criteria and if this changes they need FDA approval".

I don't see any reason for the FDA being involved as he claims , other than reviewing the G-rex changes.

HemoK' could offer some real insight but he appears to be otherwise engaged !?

Nothing more from me today.

AIMO

Hulver,

I believe that sadly the individual recruited for P3 may have deteriorated and no longer suitable for the prepared treatment.

Knowing the company are keen to change to the G-rex process for the reasons they've stated, I suspect that process is now underway and will be incorporated when a P3 is treated.

I asked both Haywire & HemoK (the main man !) for their thoughts on timescales for the FDA review of the change. Although there's an acceptance a review process is required, neither would answer!

From the research I've done , I think in the region of three months from start to finish. The company may already be well down that timeline.

However, as an alleged child killer (JHFH you're a disgrace ),... what would I know !

Ps. Yeah , also suprised the massive change in the key scientific team was not communicated directly.

AIMO

JHFH,

My question was for the organ grinder not his Monkey, I'll wait for his response thank you.

I haver zero interest in your comments, "killing children" you're a joke,..and a very bad one at that.

When you say shorters & troll's have made it harder for funding and subsequently hurt the SP, what you actually mean is;

Those who offer your target demographic the truth in contrast to your twisted narratives , make it harder for you and the crew to mug off potential investors.

You're back in the bin where you belong.

Now let's see if HK finally answers the question of timelines for FDA review and commencement of treatments with the change in protocol.

Goodbyes

AIMO

Well foolishly I unblocked the usual suspects, lifted the toilet seat out of curiosity and found a new disgusting all time low from the ramp gang!

The disgusting false claims here that the problem with the SP is due to shorter’s who are also indirectly “killing children” by preventing them receiving a cure is not only ridiculous but factually false!

Presently there’s no proven cure to be given!

At the moment there’s “SIGNS of early efficacy“ and no safety signals within P1&P2 that would preclude expansion to a pediatric cohort…full stop !

Q,So why are the ramp gang constantly inventing even more desperate and ridiculous arguments?

A,To Distract from a delay in treatments.

Where’s P3 ?

It’s all very straightforward if you ignore the noise here. The company is making a change in the clinical protocol as they advised.

That change requires communication and review by the FDA , and unsurprisingly that takes time.

To employ that change , the FDA must complete their review prior to patient treatments incorporating the changes.

Q, HK, is it better for the ramp gang here to drag this forum into the toilet with outrageous and disgusting falsehoods OR simply explain the reason for, and likely period of delay ?

I would imagine most PI’s would accept and understand a delay, given it’s a longer term positive, if simply and clearly communicated.

You can do better than this !

AIMO

Ps. This is a business . Pediatric cohorts generally respond better to Car-T treatments than Adults, fact. So yes, there maybe a change to pediatrics following P3, the reasons as above and not that, (in a time period where it cannot be proven) it’s a miraculous cure as the ramp gang will claim.

Haywire,

So you reluctantly and finally admit that the “comparability assessment” IS required,.. good boy !

Now, as to it’s importance. Until the FDA have completed their review, no further treatments can be administered 🤔

I believe the total process for submission & review may be three months.

Important ? …only if you’re interested in placings and dilution.

In the meantime, let’s quickly switch attention to CBR or other distractions, hey ramp gang.

Good bye Haywire.

AIMO

Classic Haywire !

Lots of words designed to distract and not a single word related to the question posed!

So Haywire the scientist, have i misunderstood,

Isn’t there a need for a comparability assessment?

You know there is as does HemoK but neither want to admit it, as it equates to more time which in turn equates to raising more funds, which normally equates to further dilution .

So, as to my interest. I no longer have any as i suspect there will be placing after placing with associated warrants and in the event there is any meaningful trial progress any sp raise will quickly return to baseline through those individuals and organisations with first dibs through warrants and other claims.

So, good luck and all the best to genuine LTH’s and all the worst to the ever active and obvious ramp gang here.

AIMO

I see lots posted on the delay in a P3.

Whilst sadly it could be the patient lined up for the treatment has deteriorated and now unsuitable, as some surmise .

However, HemoK was very fast to advise MDA can propose

more new candidates than available treatments, within his retort to my question of the possibility of slow candidate availability. Believing he’s the top dog, let’s put aside suspicion and presume for a moment,.. he’s correct .

In which case “comparability assessment “ as my previous post ( unanswered by HemoK 🤔), I believe is a significant aspect of the delay in P3 and onwards.

The company submission and FDA review takes time!

Previous question below.

“HemoKnowledge,

What time scale do you expect for submission of a “comparability assessment” and review by FDA/IRB for the change to the new G-Rex manufacturing platform ?

I read 60 days and that no further treatments can be administered until completion of the review. If correct this may explain some of the delay in a P3 treatment.“

AIMO

Mr I,

So i guess your prediction of the company being “snapped up” in July seems very unlikely, given the placing today !

Read Hulver’s post if you really want to understand the mechanics of the placing and those who may benefit financially and those who may not !

AIMO

Haywire,

I see you’re still churning out the consistent BS here !

So as a scientist ( alleged ) , you’re telling all here that early trial results of two patients will be submitted and accepted by ASH as statistically relevant…yeah right !

Maybe to substantiate your claim you could highlight a number of other ph1 trials with just 2 patients treated, that were previously submitted and accepted ASH.

No don’t suppose you will/can, just ramping BS as usual.

AIMO

Subush,

Nope !

Again and finally for today… i do expect early efficacy as the previous trial evidence would predict.

Although efficacy if it becomes apparent, is a positive and a step in the right direction , Durability as I’ve continually expressed, is the most difficult and significant hurdle here to clear.

Efficacy without curative durability is not as you suggest a “successful product “

I’m now out, see you at next RNS.

AIMO

Diggittt,

No , you’re completely wrong!

I called out Haywire for the inference he made that efficacy MUST have been deep and unusual to gain the FDA approval of pediatric expansion.

There is NO such prerequisite by the FDA, that my friend was my point.

I can maintain my consistent opinion that early efficacy could be expected with the point above. They are not mutually exclusive, think about it a little more before scribbling replies!

Yes i believe HemoK is higher up the scientific food chain and hence asked him and not others, the question posed earlier.

AIMO

HT,

I’m not buying until i have better insight on when a placing might be announced. I believe that hinges on the answer to the question i’ve asked HK earlier today.

AIMO

HemoKnowledge,

What time scale do you expect for submission of a “comparability assessment” and review by FDA/IRB for the change to the new G-Rex manufacturing platform ?

I read 60 days and that no further treatments can be administered until completion of the review. If correct this may explain some of the delay in a P3 treatment.

On this occasion i confess, i’m not sure I’ve interpreted the various information/rules correctly, and hence asking the scientific organ grinder and not his monkey, for clarification.

Hopefully you could point to the relevant FDA or IRB information, as without you know i/we might be a little…skeptical.

AIMO

Ps.Barbershop, CRBU is the one i previously referenced.

HT,

It’s very simple, just re-read exactly as written and comprehend !

Good night.

PeterB,

It might not be of any consolation but i too have Biotech investments of significant value, which are presently seriously underwater,..over the water.

Often those who believe they may have been too greedy with financial investments, have actually fallen victim to organised and determined ramp gangs praying on typical human nature and reaction to certain stimuli.

I’m not suggesting this in your case, just an observation on typical workings in the markets, particularly smallCaps.

Anyway, as i said earlier, i do expect good news here and hopefully my conclusions are a little off and all genuine LTH’s get to benefit. Time will tell.

Have a good evening.

AIMO

Barbershop,

Almost all my Biotech investments are in the USA. I post on the relevant platforms for those.

I have a particular interest with potential Car-T treatments.

I have been and maybe an investor here !

The volume of my postings here is insignificant to that of the organised yet ineffective ramp crew , the content not so and that’s to their annoyance.

AIMO

PeterB,

I’m genuinely sorry your investment here is not performing.

I’m also sorry you believe myself and others are overly negative.

My post today was to add to another’s opinion that pi’s here might not benefit as they’d like on possible future good news and/or funding.

There , i said it …good news!

I do expect announcement sooner or later confirming, definitive early efficacy within those treated.

Why? … because my research suggests, it’s to be expected.

As such my thoughts are any sp re-rate will be moderate with warrant holders grabbing what’s available and possibly placings into any raise, as funds are needed !

There’s a narrative on this board suggesting all pi’s should be very positive regarding the recent scientific team’s layoffs…Well , i’m not !

It demonstrates to me there’s no imminent VC funding of significance, or else why cut?

So there you have it. I do expect positive news but I’m not so sure all will benefit from it .

AIMO

Mr Jinx,

I really don’t like to, but i must agree with your analogy, however crude it may be.

Whatever form any funding may take, I suspect to use your analogy;

It’s existing pi’s that’ll be dry humped and told by the crew here, just bite the pillowcase as there’s a lollipop waiting after the painful event.

Unfortunately i suspect that sp lollipop might be hard to find with all the warrant holders beating the majority pi’s to the sweetie jar !

…Jam tomorrow !!

AIMO

Micky,

You’re 100% correct, Mr I did make that statement.

The post was subsequently deleted , either by himself or LSE admin, and rightly so.

I note he chose not to answer you!

When questions are asked which either, they can’t answer or would rather the answers not be publicised here, they simply clam up, go hide behind their collective settee and wait for their crew mates to change the thread.

So, presently;

No, the company’s not been “snapped up”.

No, the consolidation has not resulted in the investment they predicted.

No, 180p was not “the bottom”

I could go on and on listing the many claims/predictions the ramp crew here have made all of which in time proven, misleading and wrong.

Rest assured, they’ll be at it again next week.

GL Genuine LTH’s

AIMO

Kingpin,

Obviously any positive news on early efficacy, is excellent for those treated , no debate or argument.

However , why should we expect a “hard re-rate” in Sp on such news? You don’t appear to have considered;

1. Early efficacy in similar Car-T r/r AML trials with patient complete response, is relatively common.

2. The market will be expecting such news knowing the above, and also knowing;

Our resident Scientists here has argued, strong efficacy must have been demonstrated in P1&P2 for paediatric expansion approval .

I think you’ll find, as Haywire has argued , it’s a known expectation and as such, unlikely to ignite much new investor activity.

AIMO