Member Info for stu485

D,
Any change to the current structure prior to the Cart-T IND RNS would raise a massive red flag for me.
When we know truly where we are with Cart-T (post IND and FDA cleared), then I'm all ears.
Prior to, I for one would most definitely be panicking and very carefully scrutinising associated news for debate.

AIMO

HFH,
I think so too.

…it’d be great to be working in that consultancy!?

AIMO

HH,
We are both at different junctures of trust and belief particularly regarding CBR's potential and the content of the recent RNS.

All that's needed for alignment is the company to deliver Cart-T IND with subsequent FDA clearance...soon.

Fingers crossed!

Your point (1) I'd have to concede possible.
Given the time from first report, I feel unlikely as not even a whiff of interest showing in SP.

As an aside, please maintain your patience with posters offering alternate views to the majority.
Your considered and eloquent posts exemplary, giving some credibility to the otherwise questionable board.

...and now we'll both get hammered for daring to debate !!

Ps. I too have experience in the process and delivery of complex projects.

GLA
AIMO

HH,
Good post!
We agree on something, Cart-T is THE priority and the potential jewel .
We disagree on time not being of the essence. VS own words, it is IMPORTANT!

The recent posts on CBR have forced me to offer my view which I know will be very unpopular with the disciples.

The RNS on CBR was in my view, written for the consumption of a demographic of lower primates.
CBR could treat Cancer, plus any topical and scary virus you can think of, plus make the use of biological weapons redundant. I'm surprised world peace and famine were left off the list!

Were it to have a reasonable chance to resolve any one of the above, then big Pharma would have ALREADY gobbled it up.
So I believe it's purely a distraction from the real play of Cart-T. A filler of time and news flow and nothing more.

Let's land that Cart-T IND RNS and FDA clearance.
At that point, unfortunately for many, you'll have to suffer a round of my very positive and Hemo' complimenty post.

GLA
AIMO

I make a point of not disclosing my position on any stock but given the interest, yes I’m invested.

I will not disclose anything other than that, so please don’t ask.

HH,
I’m sorry I don’t accept your claim it’s all VS’s doing.

Your inference is, VS having worked on the Cart-T IND for years would be so amateurish to pencil in an incorrect date for submittal . I don’t believe he is and would.

I suspect the gang didn’t understand the communication.

AIMO

Should the Cart-T IND submittal RNS land soon and subsequently cleared by the FDA, It would be a massive turning point for Hemogenyx. Respect, understanding, trust and a rather large SP re-rate, ensuing.

On the flip side. Should we hear nothing for months on the Cart-T IND and instead receive obtuse news on CBR to try and deflect attention, or that additional quality runs and submittal works required ,with associated delay. The corner will not have been turned .The company trajectory continued and Hemo’s reputation cast in stone.

So, when is Cart-T IND RNS going to drop ?

Many frequent posters on this board got a little over excited with the prospect and through their overly confident predictions…now past, have put the company in a spot it never deserved or needed.

Considering the IND submittal work required post PQ3 is significant, (I note it’s now generally accepted what I’d previously stated), the RNS was never going to drop straight after as many prophesied.

I doubt VS is happy with the gangs recent work and newcomers should take note of it’s validity!

I don’t know when the Cart-T IND submittal RNS will land.
What I do know is the enormous positives and negatives now at stake with its TIMING.

GLA

AIMO

HH,

I agree and with help from company performance , there's no reason 200 positive post won't follow.

PING,

Seems maybe I will be eating that Humble pie , I genuinely hope I have to.

GLA
AIMO

HK,
It was me who pointed out there was no company time line from Hemo' regarding IND date within any recent RNS.
The gang then suggested I was ignorant of the fact it was detailed in some Zoom meeting with VS and had I been a true investor I'd have known it was W1 Feb target.

Now that date's come and gone they're back peddling with all sorts of muddled argument but mostly deflecting insult.

VS care's about the date for IND and progression to clinic, he's said so .
To say it doesn't matter is ignoring his reasoning why it does and the shortest time line possible has an importance other than the obvious. What that might be I don't know.

I'm happy to waste my breath with the gang should the result be even one potential investor get's the true facts.

AIMO

I'll use small words to help you understand.

A gang of LTH's are on record as stating W1Feb the target for Cart-T IND RNS as confirmed by VS himself.
There is no Cart-T IND RNS and if you check, it's past W1 !

So, there IS A DELAY against the W1 target.

...and now the Gang will avoid the fact that all can see and try to deflect with more personal insult.

crack on, every further week of delay I'll be here to remind all.

AIMO

..Nope, you said a year. I think less.

I pointed to a third party informed article that suggested up to a year is typical.

PING,
I didn't say an IND will not be submitted !

I said, ...and it now seems many others too, are concerned with the delay from W1Feb target especially when VS has impressed the importance of speed to clinic.

Let's not forget, the placing funds were supposed to accelerate the process, whereas the FACT is... it's delayed!

So yeah I'm not happy with the speed of progress on IND but I DO expect it to happen after further delay.

Should it happen this month, I'll happily take a slice of HT & Mr I's Humble pie they eat each day with no IND RNS.

I anticipate there'll be none left to share!

AIMO

Mr I

But you said the same two weeks ago !?

Ok I’ll trust your judgment and add immediately.

Thanks

Thoughts ??

HT,
Please quote me correctly!
"You will find that many of the process steps involved for IND Submittal would be impossible to start years ago and can only commence upon completion of the third run"

MANY ! I didn't say ALL and yes I did know.

At least G14 has a pretty good attempt at expressing the alternate view that the IND Submittal work is done.
You should learn from his posts.

The alternate view of course would require a Cart-T IND RNS to substantiate.
Unless mistaken I haven't seen one?

AIMO

JFH & others,
Rather than sharing your ignorance of the IND requirements, perhaps you should go take another look at the FDA website.
You will find that many of the process steps involved for IND Submittal would be impossible to start years ago and can only commence upon completion of the third run.

Are the FDA wrong !?

So maybe the timeframe for compilation of the entire IND submittal data is the reason for the delay against W1FEB target.
Hemo' underestimating the time required, as the number 1 regulatory services provider suggests ,... is a common mistake.

Just for interest, I am expecting an RNS reach next week.
It will most probably be to deflect attention from the Cart-T IND delay onto some waffling progress in CBR.

To those who ramp regardless of facts, you're not helping the company.
Potential investors, those with even a modicum of intelligence , will see it for what it is and move on.
Should you really want to help then pick you game up and ramp with a little interspersed researched fact.

AIMO

I asked the board for any researched estimates on timeframe for IND application from completion of PQ3.

No one answered so thought best find out myself !
See below, I guess that's why no one answered !

Taken from article considering top ten problems with IND applications.
Looks like that RNS due last week (LTH's), might be a very long time coming !!!

"9. Underestimating the time required to develop an IND application and complete the submission is easy to do.

It can take 12 to 14 months to complete the IND application package"

AIMO

JFH
"if there was likely to be a delay then the loyal posters would be prepping the ground, making excuses and downplaying the significance or trying to switch focus to something else." Wow, all take note!!

... like saying a target's not important as it'd self imposed. Like saying a Delay is not really delay as only short..as yet!
Like moving the focus from feb to Q1 and the through Y23, and to other projects?

Thanks for the heads up.

AIMO

G14,
There's no argument with the clarity within the recent PQ3 RNS.
There's no question that 3rd party certification isn't anything other than a normal requirement.
VS apparently confirmed the IND Submittal target was W1 Feb as LTH's , JFH reconfirms below.

So to the point.
We've just suffered another unexpected placing. The funds used to progress Cart-T and others.
VS statement "It's important that we move Hemogenyx Cart-T into the clinic as quickly as possible"

Given Hemo have more funds to progress Cart-T and VS puts emphasis on speed to clinic as an important requirement,
should we be satisfied that we've missed the apparent target date of W1 Feb ?

When VS clearly states the importance of speed to clinic, simply to say we don't care how long to the IND RNS as we know it's coming ,is missing the point. There could be competition aspects and opportunity windows at play.

Considering the above, unfortunately there is most definitely delay and to sweep it under the carpet with the, it'll all come good soon broom, is amateur !

Again, please keep posting we won't agree on this one however you make very clear and referenced argument.

AIMO
Ps. Who said I've held back from investing.