Member Info for stu485

I see CBR being put to good use , well done.

Personally, my focus is on the lead product and conformation or otherwise of Hemo’ Car-T Complete Response being submitted to the FDA this week .

AIMO

GLA

JFH,

I have highlighted the RNS company statements/wording and have no inside information.

“further funding will be sought by the Company PRIOR to the commencement of the Phase I clinical trials”

If it’s the company expectation to be clinical within 23, as stated , then it’s reasonable to conclude the further funding would also be within the year.

AIMO

JFH

Sorry but you’re wrong as detailed below .

Half year RNS ;

“The Company cannot be certain that such additional funding will be available on acceptable terms, or at all. To the extent that the Company raises additional funds by issuing equity securities, the Company's stockholders may experience dilution.”

So there is mention as above & fund raising will be THIS YEAR , should you believe the company expectation of Phase 1 within 23 !?

AIMO

JFH 13:26 post.

You are correct in pointing out the “further funding” that will take place this year , may not be through a dilutive placing. You also make a good argument of necessary funds being so significant that a placement at low SP is unlikely to fit the bill.

However, within your post addressing Mickey’s concern of a dilutive placing , i find it very disingenuous that you’ve neglected to mention what the COMPANY have actually stated regarding placements, within the half year RNS.

The company statement makes for anxious investor reading !

AIMO

JFH,

Categorically and honestly , no that’s not true.

I’ve made a researched conclusion from the facts available to all and nothing more than that.

I note not a single poster has demonstrated where I’m wrong!?

AIMO

Mr I , I generally don’t report individuals but i will make an exception for you should you make that false allegation again.

HH,

Is it my understanding of FDA timelines?

Is it my understanding of Hemo’s RNS “Expectation”?

Is it my understanding of FCA market sensitive info?

Within your lengthy post, you’ve completely neglected to highlight any error I’ve made in the conclusions reached ?

Should you have considered my post properly and without the emotion evident within your reply, you’d have realised. I have not stated the company had to RNS the Complete Response submittal,( although for reasons already explained, I’m sure they will) only , they will have to advise of a change within their “expectation” of Phase1 within 23, should they not have submitted the Complete Response by month end . That company advice, indirectly confirming the Complete Response situation.

Hopefully now clear and understood.

AIMO

The argument over Car-T IND Complete Response submission date, will be settled by end next week if not before.

Why ?

Considering the “material” importance of Phase1 clinical , the FDA timeline, and the company RNS “expectation” announcement. The company would soon need to advise a change to their “expectations” in that event.

I believe they would advise any change to comply with the relevant rules on market communication of material nature.

Until any change in “expectation” is communicated, I reasonably conclude, the company must still be on track with progress and Complete Response will therefore be submitted before the end of the month to ensure the FDA timelines are fully allowed for.

AIMO

Why the bickering and spurious speculation on Car-T Complete Response date!?

You either believe the company statement above or you don’t.

Should you believe the company’s RNS statement as i do , then Car-T Complete Response will be submitted before the end of next week*

Facts ! …See companyRNS, see FDA IND process, see FCA market sensitive information and requirements on communications.

* My personal opinion, I don’t believe it will take the entire 30day period prior to FDA response BUT the company would have to consider it may for the “expectation” communicated to be fair and reasonable.

AIMO

“Going clinical attracts a significant re-rate in terms of market valuation, validation and credibility which makes it much easier to attract investment” JFH

Completely agree!

And the good news is as RNS’d, we know it’s the company expectation for that to be within 2023.

AIMO

JFH,

I don't disagree with FDA taking less than 30 days to review and comment, it may well be a shorter period, but we don’t know that and neither can Hemo’.

We know( not opinion) , it’s a maximum 30 days.

I absolutely disagree that the company, after all the detailed and frequent updates via RNS on progress towards their Complete response submission, would now choose not to let the market know when sent .

Looking forward to the RNS advising Complete Response has been submitted, before the end of November.

HT , you’re welcome.

AIMO

9 working days for IND complete response submission! *

GLA

JFH,

The company’s been working expeditiously to satisfy the FDA requirements.

They’ve kept investors informed through RNS communications, at each step towards their objective.

…What the problem was, what’s the fix and progress with the fix, all communicated .

Now though , you’re suggesting that after all that valid communication they’ll simply choose not to advise of the actual submission!!

That would make no sense at all. Even your week argument of not wishing to allow trading is flawed, as no one knows how long the FDA will take to review and respond, only that it will be a maximum of 30days.

It would however let you and others suggest the submission has been made even if it hadn’t!

*Presumes , there’s no changed to the company’s expectation on being clinical within 23. None has been communicated .

AIMO

OB,

Or you could have been constructive and explained where I’m wrong?

AIMO

OB,

A deal.

You or any other explain as described,where my rationale and assertion is incorrect and i’ll leave the board.

If i was short as you claim, why would i be advising of my conclusion of a full response being made before the end of November !?

AIMO

Ping,

Are you in a playground, enjoying the slides?

If you could explain where my rationale is flawed in concluding that EITHER a complete response ( some preferring to describe as IND re-submission ) , will be made BEFORE the end of November OR in the absence, the company is required to advise of a change in their expectation of phase 1 clinical within 23 in RNS, then you could describe my previous posts as stupid.

I have only referenced company RNS information, FDA process timelines and FCA notice requirements.

I won’t be holding my breath for a contrasting conclusion which properly considers the same.

AIMO

HH,

Had you read and considered my post without emotion, then you’ll have understood,all i’ve said is;

I’m looking forward to the complete response being submitted within November or an announcement ( RNS) that the Phase1 clinical “expectation” has changed.

Seems to be not very sinister to me !

AIMO

HH,

You’re overlooking a very important point in your paranoia.

The company will have to advise an update to the expectation of Phase 1 clinical trial within 23 should they not submit the complete response within November.

I’m not trying to create a deadline the company already have with their RNS’d “expectation”.

You should be happy in anticipation of the company delivering on their expectations, rather than make attacks and false allegations.

AIMO

“Dawn raid” @ Andrew.

JFH,

Probable !!

I know you can count so kick of your slippers for fingers and toes available, now if Hemo’s going to be clinical in 23 as their “expectation” and the FDA have 30days to review and comment/clear , when MUST the Complete response be submitted?

Should you arrive at any date later than November, then you are indirectly but clearly calling out the company 23 clinical expectation.

So which is it !?

AIMO

JFH,

So you agree the re-submission must be made in November for the companies expectation of being clinical in 23 to be maintained?

AIMO

JFH,

I’m sorry but you do not know how long the end to end works the company have described are now required will take and neither does anyone else on the board.

There’s also no need to guess as I’ve just explained!

According to the company RNS and their expectations on phase 1 clinical, it has to be re-submitted within November.

No need to sweat it !

AIMO

RNS

“Phase I clinical study, expected to commence in 2023”

To the best of my Knowledge , the company has not updated the above expectation within more recent RNS’s.

So, for 23 to be their “expectation” and knowing the FDA have up to 30 days to respond to the re-submission ( which they must factor in the full term for the “expectation” to be fair & reasonable ) , the re-submission must be made before the end of November .*

So either re-submitted by end November OR a further update advising it’s no longer their “expectation” to be clinical within 23.

The company cannot simply neglect to advise a change within their “ expectation “ given the material difference the update would make to the SP and the associated and relevant rules of notice.

So in short, LTH’s should be very happy to receive news of the re-submission before the end of November and have no need to make spurious estimates of there own.

AIMO

GLA

* Does not allow for any holiday period within December.