Member Info for HedgeHogarth

Or maybe Roger is half right, looks like someone is dumping :-(

There you go again Roger - boring....

MCap of less £1m when other shells valued up to £5m

Nothing pump and dump about that

Good luck Guinness.

Great to have you on board.

Mr India. May I congratulate you on a cracking post. Thanks for sharing. Your best ever post by a long way

Lets all remember that nothing goes up in a straight line. I'm sure holders will be rewarded but the rises and dips will be hard to predict.

You are right Digitt - It has only just gone public

Although Vlad has shared stuff in RNS, Investor calls and at a Biotech Conferences i believe.

From my experience of pitching Business ideas - Vlad will not get an opportunity to go into much detail on his pitch.

Vlad has 4 minutes to WOW them. He'll need to be super succinct and have some great sound bited

Then 9 mins of questions.

Hopefully he'll have more opportunity offline after the pitch from interested investors

135 investors are pictured as confirmed attendees. It sounds like a great opportunity

Good luck Vlad

I do not believe you want this to go up Roger right now - why else would you dedicate so much time and effort to posting negatively on this board.

I don't disagree that there will be people on here who have bought shares and want it to go up so they can sell for a profit. Surely that is what trading and investing is all about?

Besides if a share price goes from 1.5p to 3p in a matter of days, any investor with any sort of sense would expect some profit taking at some point which could results in a dip. Whether that price is 3p, 5p or 10p - who knows? We've all been in situations where we have sold woefully too soon. (and situations where we have waited too long to sell)

The SP has gone up significantly today on very little volume. It has also sustained a fair bit of selling into the rise.

So most of what the more positive posters on here been saying appears to be credible - small free float, demand for shares etc

I have some shares that I bought between 2.1 and 1.5. I also managed to make some money on the last rise having bought at 2.5 and sold at 4

GLA - hopefully we'll see a few hands revealed soon. An RNS would be nice and a bit more volume as well

Genius

There you go again Stu

I have repeatedly stated that my post is based on my opinion. Every point is factually correct according to the downloadable FDA guidance available here:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submitting-and-reviewing-complete-responses-clinical-holds-revised

For me the only "question marks" are why the RNS talks about re-submitting IND as this is not addressed in the FDA guidance and why Hemo has not used the term "complete response". The latter could be because it is FDA jargon OR it could be because Hemo's FDA response was an interim communication ahead of submitting a complete response.

But based on the "definition" of a complete response in the FDA guidance - I am taking the opinion that Hemo did submit a complete response.

That is my prerogative - It is my opinion and interpretation.

I don't need or want another comment from Stu on my post. It is very clear that he disagrees with me and it is also clear that disagreeing with me serves his agenda.

GLA

I agree Bline - and I apologise for any role i have played

I am just sharing my opinion - it's genuine, open and honest. Time will tell if I'm right or wrong.

It is however very frustrating when a single poster keeps commenting negatively and suggesting I am wrong. Perhaps I will be proved wrong. But at this stage, Stu is not qualified (as a pesky, tin pot trader) to be judge and jury on whether I will be proved right or wrong.

Note: This is not a factual response from Stu - It is his opinion

In the same way as my view - is just my opinion. It does not change regardless of Stu's opinion of it

As ever with Stu (a perennial trader with a history of manipulative posts) his post paints a very negative slant on here to reflect his motives.

My view is on based on my research, but will also reflect the trust i have in Hemo. I'm no scientist - so It's my best effort to interpret the FDA guidance - which to me feels very clear

GLA

JHFH - There is no reference to having to re-submit IND in any of the FDA guidance I have found.

The key to the process is a response - limited to addressing the issues for the CH.

For me, re-submitting the IND is BAU Admin to reflect the changes agreed with FDA.

AIMO

Mode are trading at c£3m with less than £1m Cash and a £1.6m convertible loan liability

Stu - I have shared my interpretation, no more, no less.

May i correct you last post - I'm saying that the CH is effectively lifted already. Hemo addressed issues and FDA accepted them.

I believe the next steps are about admin, tweaking and testing that Hemo will complete to incorporate the change and some others to improve safety before they start trials.

I may well be wrong - time will tell.

Either way, just like Vlad said at the AGM investor invent, they are confident they can address the CH and will be taking CAR-T into the clinic. The latest RNS adds weight to that statement - the FDA agree with Hemo.

They have a partner lined up and ready. And Vlad baulked when someone suggested a 1 year delay - saying he was expecting to get going much sooner.

Good luck all and apologies to HemoTruth if he found this exchange tedious. I just felt that given the clear FDA guidance, it was useful to surface in parallel to the brilliant RNS today

Dom Bella - CCAP had about 3 times the number of shares

I don't believe the volume of shares is hugely significant. It's about the mCAP

We're barely over a £1m here right now.

Stu - try as hard as you can but my post and interpretation is genuinely credible. Whilst HEMO did not use the words "Complete Response" in their RNS - it is very clear to me that they did.

How does the FDA define a COMPLETE RESPONSE?

A response from the applicant in which all clinical hold issues identified in the clinical hold letter have been addressed

So let's break it down...

Did Hemo respond to FDA - YES

Did Hemo address all clinical hold issues identified in the clinical hold - YES, It was single issue

Did FDA respond within 30 days - YES

Did FDA AGREE that Hemo's response addressed the issue causing the CH? YES

This is all according to FDA's guidance document which is crystal clear

Losing a few weak hands at c2p - very low volume

We only need a sniff of a deal and this could go to 10p (£5m mCap)

CCAP, before its deal fell through with Smarttech - traded at £5mCAP for and sustained it for 2-3mths. Previously it was c£3m mCAP for 6mths

It only had £700k cash

Each 10p on this share price is just c£100k of mCap

A 4p share price equates to a £2.2m mCAP - most shell's I have followed in recent years go well beyond £2m mCap

It really does look like MMs are short of shares and/or someone in accumulating in the background

Someone did well to scoop up the 400k sold at 10:34. Snapped up at 1.87 just after 11. And delayed reporting by pesky MMs

What happens when the FDA imposes a clinical hold?

The Agency communicates the clinical hold to the sponsor, usually in a teleconference - TICK (June)

Within 30 days from the date of the teleconference placing an IND on clinical hold, the Agency

must send the sponsor a clinical hold letter, signed by the Division Director or Acting Division

Director, that describes in detail the reasons for the clinical hold - TICK (early July RNS clearly stating ONE issue)

If the sponsor addresses all of the clinical hold issues identified in the Agency’s clinical hold letter

(a complete response), (RNS Sept - Hemo responded in August 2023 with a detailed plan, supported by laboratory tests)

FDA must respond to the sponsor within 30 days of receipt of the complete response (Hemo confirm in Sept RNS that has now received confirmation from the FDA that the Company's plan satisfactorily addresses the agency's comment)

How does the FDA define a COMPLETE RESPONSE?

A response from the applicant in which all clinical hold issues identified in the clinical hold letter have been addressed.

What happens if I think my response is complete, but the FDA disagrees?

If FDA finds that your response is not complete, FDA will notify you as soon as possible by

phone or other means of rapid communication, but no later than 30 days after receipt of your

response. The Agency will tell you what information is needed to make it a complete response.

The 30-day clock will not start until the FDA receives what it believes to be a complete

response to the clinical hold letter. (THIS IS NOT THE CASE - NO MENTION IN RNS THAT FDA DID NOT BELIEVE HEMO HAVE ADDRESSED THE CH)

Should non hold issues be addressed in the response to the Agency’s clinical hold letter?

No, even if the Agency includes nonhold issues in the clinical hold letter, you should ensure that

the complete response to a clinical hold letter contains no material related to issues other than

the IND clinical hold. If you wish to address any nonhold issues raised by the Agency, please

do so in a separate amendment or letter.

This is taken directly from FDA guidance for sponsors who have a clinical hold placed on their IND. Based on the recent RNS from Hemo and the guidance from FDA - its looks very clear cut to me that Hemo submitted a COMPLETE RESPONSE and FDA have accepted it.

My personal opinion is that whilst i cannot find it written in the FDA Guidance - It is the responsibility of Hemo to refine IND with any changes or test data that was detailed in the Complete Response.

Ahead of trials, i expect Hemo are working on a few other tweaks following the feedback from FDA to improve safety and I'm sure more testing will be involved.

I have no doubt that Hemo are fully focused on starting Clincial Trials ASAP (as per RNS) and , like today, we'll have another great RNS in the coming weeks.

Brilliant News, gl to shareholders