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…as much as I dislike agreeing with SZ , he is correct on one aspect .

The company have said they are confident “they” can resolve. So it’s not simply an FDA backlog, it must be FDA concern’s that Hemogenyx themselves are responsible for.

I’m not however saying there is no FDA backlog.

AIMO

2/2.


The FDA concerns.


As previous, i think CMC and Toxicology are most likely the areas of concern. I referenced an article to substantiate why. 

The article below explains Toxicity and CRS risks associated with Car-T treatments.



The toxicity not necessarily related to cohort reproductive and developmental risk but a generality.

CMC aspects that may be other FDA concerns, i’d suspect revolve around repeatability of quality and sterility through the process. Why?

It’s one of the common areas for CH in this field and other Pharma Car-T products have had CH for this reason. Independent article’s available to substantiate.



Coincidentally, the article also describes NK Car-T as a competing technology.

I’m not suggesting this is the specific technology that could trouble Hemogenyx just that they do exist and hence the need for speed to resolve the FDA concerns and clear. 



With the research information easily available and considering what the company has said and more significantly, NOT said , i think it now very easy to arrive at a reliable conclusion on the question, quick fix to FDA clearance or not !?

Unfortunately i now except to hear very little of substance on Car-T, with the void filled with unimportant and distracting CBR updates.

I hope for genuine LTH’s (and my remaining holding!), that i’m wrong and look forward to any reasoned arguments to why and where!?



AIMO



https://www.cancer.gov/news-events/cancer-currents-blog/2020/car-t-cell-therapy-lymphoma-reduced-side-effects#:~:text=While%20the%20therapy%20can%20lead,can%20be%20severe%20or%20fatal.

1/2.

This is a long post!

Before you judge please read it all , consider the independent references , i’m then happy to learn why my conclusions are incorrect.

Q, What are the FDA concerns,how quickly can they be resolved and is there a limited window of opportunity to resolve.

Regarding the timelines.

There seems to be much confusion over how long the company has to submit a complete response to the FDA.

My understanding is it’s up to 1 year from CH.

After which the IND is given inactive status.

Some on this board are suggesting they’re unconcerned should there be a lengthy period to resolve and patience is required.

In terms of their individual feeling, that’s their prerogative but from a company perspective is there an important business need for speed of resolution.

I think there is and suspect it’s concerning the advancement of competing treatments for AML.

VS made this statement within a recent RNS.



“It is important that we move HEMO-CAR-T into the clinic as quickly as possible”

Some have suggested it simply reflects VS concerns for potential patients. Whilst that is a possibility, within the context it’s written I strongly believe it’s reflective of a pure business need.

That need being Hemo’ Car-T may well have a limited window of opportunity for advancement before other competing technologies and treatments render it obsolete.

AIMO

TBC - FDA concerns

BS ,

Yes that’s also a possibility, and i don’t doubt VS’s moral compass when it comes to his desire to develop a treatment.

For me It becomes a question of probability.

With the research I’ve done and shared , independent referencing, i know what’s more probable.

AIMO

CD,

Q, You ask, Is it really a big deal for a six month delay?

A, VS think’s it is !

RNS statement.

“It is important that we move HEMO-CAR-T into the clinic as quickly as possible”

Could the company concern of speed to clinical be due to competing potential technologies and treatments for AML?

AIMO

Haywain,

Respectfully, I’m not sure you understood the point.

There’s toxicology in it’s generality to overcome in the first instance associated with CRS before potential reproductive and developmental toxicology is even considered.

Hopefully explains better.

AIMO

Chris,

I’m pleased to see a post that actually tries to answer THE most important question with reference to independent data.

More of the same please !

I’d agree Toxicology is likely to be one of the FDA concerns but not that associated with reproduction and development within the candidate selection.

As previous, i think CMC and Toxicology are most likely the areas of concern. I previously referenced an article to substantiate why.

The additional article attached explains Toxicity and CRS risks associated with Car-T treatments.

The toxicity not related to cohort reproductive and developmental risk but a generality.

Coincidentally, the article also describes NK Car-T as a competing technology. I’m not suggesting this is the specific technology that could trouble Hemogenyx just that they do exist and hence the need for speed to resolve the FDA concerns and clear.

With the research information easily available and considering what the company has said and not said , i think it now very easy to arrive at a reliable conclusion on the question, quick fix to FDA clearance or not !?

AIMO

https://www.cancer.gov/news-events/cancer-currents-blog/2020/car-t-cell-therapy-lymphoma-reduced-side-effects#:~:text=While%20the%20therapy%20can%20lead,can%20be%20severe%20or%20fatal.

Charles,

The date at which the FDA advised a Clinical Hold, i think does not in anyway offer insight on the gravity of the problem(s) or otherwise.

The FDA concerns are typically first verbally communicated within 14days of submission receipt. There’s then a period of time for the sponsor to respond with resolutions which, if successful results in clearing.

The FDA may well have considered the problem(s) serious at an early stage but not place Clinical Hold until Hemo’ were given sufficient opportunity to resoond.

The fact is we have no idea if serious with associated lengthy time periods to resolve or not.

The date of CH does not help us in this matter of understanding.

That’s why I’m so disappointed and suspicious as to why the company are presently choosing to keep it that way.

AIMO

Mr I,

So that’s a no then ?

…it’s a pretty bad state of affairs and says all you need to know if the main topic of discussion is my shareholding !

Any thoughts on what Hemogenyx are actually doing .

I do as my earlier post.

AIMO

BS,

A reasonable question and so i’ll answer.

Firstly, i am a shareholder and will remain invested for now.

I’m hear to debate issues and share information that could determine the trajectory of the SP , good and bad.

Unfortunately I’m having to post more frequently to correct the misleading and untrue postings from a hard core of others . The title of this particular thread a good example , where one of those mentioned makes an untrue statement to support a misleading argument; ie nobody knows what the concerns with Hemo’ Car-T, whereas and in fact they do.

Your question of why would a shareholder highlight any negatives implies you believe that to be wrong.

Well I don’t think that’s the case.

I will highlight what I believe to be the true situation on any and all substantive issues be that good or bad.

Presently there’s little good to debate !

The fact I’ve been correct in my interpretation of situations has angered the ramp gang who work on this platform.

I don’t believe my posting influence SP but i do know they’ve influenced some on hear to better research and consider RNS statement and go on to make better investment decisions of there own.

The ramp gang have tried many tactics to discredit my posts , ridicule and intimidation their go to, but many others too , none of which are going to stop me posting the Truth.

As for Hemogenyx and the future .

I can see you’ve forensically studied my postings, so you’ll know, on occasion i can and do defend the company.

Presently, I’m very unhappy about Vlad’s Tranche 1 stock options and amazed others aren’t.

I’m very unhappy about the lack of communication regarding the FDA IND concerns.

I think there’s now a desperate need for companies with more experience and financial resources to help progress Hemo Car-T. Unfortunately with limited resource and the FDA hold Hemogenyx are not in a great negotiating position.

However there’s a chance it could all be pulled out the fire with either a sale of Hemogenyx Car-T or a beneficial partnership.

Without i think it’s game over due to the speed of other competing technologies and treatments.

Fingers crossed .

AIMO

Mr I,

Go tangle with some lower IQ’d posters.

I’m sure they can resolve in a time scale of years and with lots more funding and by then , it could be an obsolete solution.

AIMO

HH,

“Nobody really knows what exactly why the FDA placed a clinical hold”

Well Hemogenyx know and that’s why they claim to be “ confident “ in resolving.

So actually yes, both the FDA and Hemogenyx know!

For once , I actually agree with your big call.

AIMO

Me I,

Yeah that’s right were in a downward spiral because of an admin error…very, very silly post !

AIMO

Mr I,

Just take a breath and look at your post!

“I am hopeful that the stoppage is either an admin problem that can be resolved or clarity that the FDA needs. 29th day stoppage signifies time ran out and they couldnt approve a life saving drug”

This a classic example of why you’re never taken seriously!

An Admin problem !!?

Hadn’t got rime !!?

Just ridiculous rambling ramp.

AIMO

This will be my last post on this particular subject , time to move on.

I’d just like to finally ask JFH,HH,HT,Mr I and all the others who constantly stated the IND clearance for Hemo’ Car-T submission was 95% to reconcile that with Vlad’s statement of FDA IND clinical holds being…common ?

Any answers that square that particular circle I’d be pleased to read .

AIMO

Charles,

Most of the reason i post is to try and prevent financial loss for those less experienced with the manipulative ramping posters and their intent to lure in the unsuspecting.

.

I detest those who are happy in the thought they’ve potentially raised the SP to their selfish benefit by luring in the unsuspecting investors with untrue postings , suggesting multi bag is all but guaranteed.

Just like the ramping of FDA clearance at 95% chance, whereas Vlad himself states FDA clinical holds are common place !

Some of the unsuspecting individuals have been brave enough to admit they’ve been victim to the rampers antics , Mickey etc. These people have my full compassion and regret.

However, HT I believe to be a ramper, and so i make no apology, i hope he fully reaps what he sows.

AIMO

Sorry HT,

P’s sort of shown you up a little.

If you want me to stop running circles around you and the 95%ramp gang, just ask nicely!

AIMO

Stu

HT as long as you keep giving me the encouragement, I’ll hold and post.

Thanks again.

Stu

Looking forward to the distraction to pick up pace.

AIMO