Member Info for JustHereForHemo

Useful link: https://twitter.com/Barneyboysrb/status/1664205655085924352?s=20

Exactly stew, let me quote:

“Listing Rules. The key Listing Rules affecting business updates are in the box "Key UK Listing Rule obligations". In summary, issuers must notify without delay major new developments that may affect their business if the development may lead to a substantial share price movement. Issuers must also notify without delay information concerning a change in financial condition, performance or expectation of performance if the change would be likely to lead to a substantial share price movement“

And now let me quote from the FDA:

"An IND application may go into effect:

30 days after FDA receives the application, unless FDA notifies the sponsor that the investigations described in the application are subject to a Clinical Hold; or

on earlier notification by FDA that the clinical investigations in the IND may begin. "

So the market KNOWS that after 30 days if there is no clinical hold the IND application goes into effect, by my reading BECAUSE its a known fact the FDA have 30 days then by notifying the market of the APPLICATION and NO notification of a clinical hold there is no need to say "30 days are up" UNLESS the FDA notify them early, like in the next day or so.

I really dont want to get into an argument about this, because honestly its pointless and waste of time and for the record I believe there probably WILL be an RNS next week, I personally just believe it will encompass the signing of the master agreement with the partner. My point is simply that by the letter of the law I dont believe Vlad HAS to notify acceptance of the IND because its simply a 30 day waiting period but he DOES have to notify if there was a delay due to a clinical hold.

As you say its just MY opinion, disagree if you want its hardly like it matters, you think RNS next wednesday saying IND accepted, I hope your right, I think RNS next Thursday or Friday saying Master Agreement signed and start of clinical trials, I am fine with either scenario :P

I am with MrIndia on this one, PER THE FDA:

"Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. "

We are currently within that 30 days, the application was notified to the market as is required and we are now waiting 30 days. IF the FDA respond and say "Yes Crack on" I believe Hemogenyx would RNS that, but if the FDA simply do not object, what would an RNS say? "We waited 30 days and the FDA never got back to us so we are going to crack on with trials?"

I repeat, the wording is:

"Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. "

We know this as we can read, the market also knows this and knows that after 30 days they can "initiate clinical trials", the partner also knows this.

I am sure there will be an RNS but my gut feeling would be it will be a few days after the 30 days and will be to announce the signing of the master agreement with the partner and the commencement of the clinical trials process following the FDAs acceptance of the IND.

But again, the IND process is NOT a secret its not Vlad or Hemogenyx who wrote the book, per the FDA:

"Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. "

https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application

If you dont like it take it up with the FDA, but hurry! your running out of time!

Dont always believe your eyes. Do a dummy buy and see what price you are quoted.

2.3184 is the price to buy which means less than 1k shares sold :P

The more positive posters amongst us dont want to leave the forum to be dominated by trolls like would happen. Take Stu's posts today, which got repeated several times, to yourself and I and most others, its obvious but if people dont answer then there is always a risk that some shareholder who does not closely follow hemogenyx might stop by, read it and take him seriously.

There is also the fact that we are getting into a hugely exciting period and people, myself included are getting restless, not because we want to sell or get out but because it feels like we are finally about to win. It has been a very long journey getting to this point and its almost over, we are about to go clinical and with that the re-rate, the validation of saving human lives, the faith being rewarded. Its very hard to stay quiet :P

Priceless, but love it :-)

So basically Stu what your saying is yesterday you saw it 14% up, volume and chat had dropped off, you as always wanted to trade so you sold a chunk of shares, you say half so I am going to give you the benefit of the doubt and say this is yours:

30-May-23 16:15:28 2.24 750,000 16.80k

You assumed, correctly I believe, there would be no RNS until the end of the 30 days and hoped that following a strong blue day yesterday it would dip this morning, it didn't and you started panicking and posting all day hoping to induce some selling.

Here is the thing.....

1, My god, you made yourself out to be some big trader but yet you held 1.5m shares? Seriously?

2, The most you could have hoped for was a few hundred quid profit and for that it would have have had to have dipped at least 5-10%, The effort for such little profit vs the risk is just pathetic, I made more than that doing actual work BEFORE lunch.

3, You assumed people would sell when the vast majority of people here are only too aware that the FDA have 30 days, yourself included. If they were going to place a clinical hold they PROBABLY would have done it in the first 14 days HOWEVER 95% of cases there is no hold so the chances of a hold at this point is so slim not even you think its likely if you did, like HT says you would have sold and went elsewhere, you just wanted to try one last trade to bank some profits.

4, You really embarrassed yourself with that utter sh173 about the warrants, nobody and I mean nobody can be that stupid to think warrants are issued at a TARGET price they expect the SP to hit at some milestone in the future. They are issued at fair market price at the time of issue, I am surprised there is a difference in price, certainly not disappointed but it was not necessary, they easily all could have been 2.5p, any vesting awards I had in the past were always at current Share Price on that day.

5, Finally, Wow, just wow. IF your being honest about your holding then WOW.... The efforts you have put in to deramping to trade hemo over the past god knows how long for that????????? Its actually cringe worthy, its embarrassing, my kids have more than that in their Junior ISAs. Honestly I was telling people that I actually thought you were switched on, knew what you were doing and like the smart version of one2one. I was convinced your BS arguing that black was white when the FDA documents were right there was an act, that your misleading BS about warrants was all just your attempts to confuse some idiots who didnt know better, but now? Are you actually this thick that you believe this cr4p you spew??? My god, you have made my day! Well enjoy either buying back in higher or settling with your 750k shares.

NT to buy again, lets face it this is no different to a used car lot, when there is not much stock good luck asking for a hefty discount. When there is cars parked out on the main road you can set your own price. Right now there is a waiting list.

Said this morning, SP moved up not long after 8:10 and has been static ever since even though there was no trade printed when it did move up. Fact we have not seen a trade from that time means there is probably still an order not filled.

Its not NT to encourage people to buy, its to put people off in the hope that there will still be people selling. There is nothing illegal or untoward about it.

I am indeed!.... Welll...... Mrs JHFH is :P she is the one who will be worth the millions if this ever takes off lol! *(Just dont tell her ;-P)

Ya, just checked offer max of 10 shares at 2.3p for a grand total of 23p, on top of which I would pay £3 commission so no thanks!

Always a good sign when the available stock dries up, like everyone else I predict a tick up this afternoon, going to be an interesting FOMO Friday this week with the 30 days running out next week!

Cant.... even... find... the.... words... :-D Ok, yes dear, your right, have to go now, have a good day :-)

Err.... no way your being serious lol!!! Not a chance :P 121 MAYBE but come on, your trying to convince us that YOU actually think that options grant price equals VALUATION? Catch a grip!!!! They picked 2.5p because that is roughly what the SP was at the time of the grant, its the same for just about every other company out there that has any sort of employee share scheme.

ANYONE who reads your posts and actually buys into your "Theory" and has no clue about how share options etc work deserves to fall victim to you, good god, cringe worthy!!!!

https://www.lse.co.uk/rns/HEMO/equity-incentive-pool-increase-and-option-grant-vkxs1g1nxdxcu43.html

From Stu: "Hemogenyx have clearly stated what they believe to be the Re-rate Sp IF they gain FDA clearance."

Good god I seriously overestimated you!!!

You do get that options are a REWARD for him. If they THINK that a fair valuation is (I am picking a stupid number intentionally) £10 per share and they issued him options at £10 per share then if the SP actually hit £10 per share, he would get SWEET FA. If the SP only hit £9 he would actually LOSE money on the options if he tried to take them even if the SP went from 2p -> £9.00 if he got options at £10.

Why the heck would anyone, especially a CEO Issue themselves share options at the TARGET price they predict the SP to hit???? What planet are you on and what planet do you think Vlad is living on???

L200 it moved up at 8:10 when there was no trade reported so fair to say it was on a trade thats not yet reported.

Either way you can just tell, the Market Makers are inclined to move the SP up, which I know will dissapoint the traders who sold towards the close yesterday hoping to buy back lower this morning, but s417 happens and thats life. Its clear the MMs are moving it up, and as we are now what? 5 trading days or less until the 30 day window closes? Who except the odd trader is likely to sell? 2.6p today? entirely possible but who cares, we are moving in the right direction and its a sunny day outside.

2 Kids sports days today, check in later, have a great day fellow shareholders and traders having a go :-)

"Hemogenyx have stated what they believe the Re-rate SP should be IF they gain FDA clearance for Hemo’ Car-T.

It’s written in clear English within a company RNS."

REALLY????

Hemogenyx have published brokers notes which include peer valuations and a comparison to the current mCap of Hemogenyx but I have never seen them publish a re-rate SP target in an RNS and I believe your incorrect!

Seible, over the next 1-2 years I expect to see Hemogenyx to be a billion dollar company, not based off HEMO-CAR-T but from CBR. CAR-T is still the new kid on the block however there has been enough time to prove the science and multiple licencing deals in the market to provide a baseline for potential valuations.

https://www.baybridgebio.com/drug_valuation.html

https://www.toptal.com/finance/valuation/biotech-valuation

The above are just a few of the many links out there to help value early stage bio's, there are break downs of percentages of success and discounts applied at each stage etc. Worth noting most are per-drug as well, so like for one example value of HEMO-CAR-T at start of program 3m and value at start of phase 1 of 105m, at the very end 1bn+ (USD).

Based on other companies with just CAR-T treatments in phase 1 trials I see valuations of 150-300m as very realistic and likely once this gets traction and trials have started. Do I expect that next week? Probably not, I think this will re-rate and start to move towards a fair valuation as publicity and volume increase but accept it might take a bit of time.

My FIRST target is 5p, I want to see Hemogenyx breach above the 50mil mCap and be classified as a clinical pharma, I have heard from many people that when that happens we should see II's and funds starting to buy in which will reduce the free float and provide some support to the SP. So that is my immediate target, around 5p and I fully expect to see that next week, is that a re-rate? No, but its a good start. Get us above 5p/50mil mCap as clinical, then await the partnership with the partner to run the trials and see where we are then. After that in vivo results proving that CBR works and potential CDX licencing deal etc and.....

Anyway, touch wood, 5p this week or next to start and I am happy :-)

Well under 10% but its a start. The clock is ticking, one more week to find out if the Bulls who predict a significant re-rate are right and find their faith rewarded, or perhaps the bears who think ~20mil is a fair mCap for a Clinical Pharma in Human trials with a CAR-T treatment for oncology are correct.

I know where my money is placed, ALL my chips are firmly on Hemo.

This re-rate has been a VERY long time in coming, trolls have gone silent because they know its out of their control now, its out of Vlads hands also, we are not playing by Hemogenyx time scales any more.

We await one more week for the FDA and then its into trials with a partner who knows what they are doing. Exciting times to be a shareholder :-D

Expect the american markets to do well after they agreed to lifting debt limit, crisis averted!

Traveller, I am not going to disagree that there are traders in there who may have bought today and will sell on news, HOWEVER at the same time they have bought today and helped push up the SP and with it if even a few have taken a few million shares and will hold for result that all helps to shrink the float. Given the short window until news its likely a good few will hold and maybe add so we should see more blue in the coming week which sets us up for a much higher SP when news does land.

Going clinical IMO will be big and will attract visibility and external investors. I would rather they come in at a much higher price than 2p. We all know that people will sell at 100% irrespective of what the SP is, a bag is a bag so its better to bag from a much higher starting point!

Either way, its blue, one week to go, lets get this re-rate started!

Many of the listeners know the name Hemogenyx but its fallen from the common lexicon and with no discussions or talk about Hemogenyx why would any of them think to venture here or anywhere else to find out?

I have said it before, this is an echo chamber, people waste their time here talking to existing shareholder who know whats coming. We need external investors to look in.

There is no need to ramp or sell Hemo, you just need to convince people to look.

Thankfully its very easy to promote hemo at the minute, everything is in black and white. There is an RNS for IND application, there is NO RNS or any indication of a delay and per the FDA documentation its a 30 day review, of which the days are running out. It really is that simple.

CBR, CDX, Hu-PHEC, all those are great but right now irrelevant, do we have enough with JUST HEMO-CAR-T to justify a rerate in the very near future?

Yes.

I had a chat this morning with Doc on his podcast, perhaps a few buyers off the back, Hemogenyx is a gift but its just under the radar, it will not take much for interest to return. We need visibility, pr and volume, all 3 of which will come with progress!

India, dont worry about sellers, as the saying goes "Shares are for selling", we are ALL sellers at the right price. Provided there are enough buyers to balance out its all good :-)

And why would there not be?

By my calculation its 22 days post IND application with days 1-14 being the high risk (of a relatively overall low risk) of any sort of delay. Which leaves 6 trading days, touch wood assuming no issue from the FDA, until Hemogenyx are clinical!

I dont want to over sell this, and if my reading is incorrect more than happy to be corrected as I want to be accurate, but its my clear understanding that 30 days POST IND application if there are no objections from the FDA, Hemogenyx ARE allowed to start trials.

Any clinical hold would be market sensitive and to date, silence. So all being well... Next week or sooner, Hemogenyx are CLINICAL.

HUGE leap from testing something in a testtube in a lab in NY to suddenly human trials run by proficent well known established partner with experience and credentials in running trials. With a proven technology (CAR-T) and demonstratable market licencing deals closing in on the 1/2bn zone.

Validation for ONE candidate has a positive impact on the acceptance of the other candidates such as CDX and CBR which will have to be taken seriously, one of which being a potential off the shelf cure-all for all viral infections.

This Share price, at this point in this companies history is pure and utter bonkers, the mCap is wrong and its not sustainable. Existing shareholders have the advantage right now of knowing the potential because there is NO PR, there is NO big traders or groups talking about Hemogenyx, its NOT on any of the pharma news outlets, its not on BBC, MSNBC or CNN.

This drought of news and publicity and volume WILL NOT LAST. We are not on Vlads timetable right now, we are working to the tune of the FDA and the sand of that timer is about to run out!