Member Info for JustHereForHemo

Honestly guys, you have entertained me and given me a good start to the weekend. SP is up, you bell ends are out and the only thing that would make this better is a 7am RNS about CBR or something to really ruin your weeks.

I get that your trying, badly, to inject a bit of doubt into the less confident or casual browers of this forum, but you do get how stupid your arguments sound right? Surely by now you have read the actual FDA website and know the process? Thats the least I would expect, you do know how your coming across right?

Oh and Stu, I am very familiar with what happened at POLX, but YET AGAIN your getting yourself all confused

That was an NDA NOT an IND:

https://www.lse.co.uk/rns/POLX/new-drug-application-resubmission-pbdt6tefbgodly3.html

So 121 you now want me to email the FDA about something? Honestly your just throwing words at the page now hoping to push any positive posts off the page right?

Stu, good stuff NOW we are getting into it, first off please go ahead and share those stats. HOWEVER you have fundamentally undercut your argument, your talking about success and approval of the treatment or the NDA process which is ENTIRELY different to the initial IND application.

There are multiple phases as you know and getting from Phase 1 to commercial is a very long process and for AML there have been very few successes which is why the opportunity is so key for Hemogenyx.

But your basic argument for why YOU say there may be delays is because approval rates for the ENTIRE "submission to phase 3 are much much lower"

YES!!! 100% I agree, on the face of it failure rates in trials for AML treatments have been very high! Survival rates are very low, this is all true!!!

IT DOES NOT CHANGE THE FDA IND APPLICATION PROCESS.

Hedge, the advances in science lately have been huge, I hope very much that your mum is able to get a treatment that works. If Hemo does as well as we hope perhaps the money will give you options to get treatment otherwise not available on the NHS, either way sorry to hear she is ill :-(

One2one, the FDA have 30 days, the IND application lands with "A Team" such as Medical, Chemestry, Pharma etc. That team might very well not be working that weekend and might not even notice the IND, it may very well go to the wrong team and need re-directed. This happens at the start of the week which is why it may sit in the wrong mailbox for days robbing the correct team of days they need to review. If you dont accept that then go and argue with the FDA, not me.

Stu, pretty sure, unlike you, I copy and pasted the EXACT and full comment from the final results which are clear.

Hemogenyx put in the effort to minimise the risk of delays or questions. Now I am not saying that there wont be any questions, certainly they have been talking to the FDA for over a year in regards to this IND so the lines of communication are open.

What I am saying, AGAIN, is that I cannot see a mechanism in the FDA IND review process to delay the commencement of Clinical trials beyond 30 days without applying a clinical hold. Within those 30 days? Sure ask anything they want, and if Hemo dont reply and satisfy them and there is grounds to apply a clinical hold? Go for it!

But the fact is that 90-95% of IND applications do NOT experience a clinical hold.

Hemogenyx have taken extra time to make sure they answer any potential questions in advance and have brought onboard experts in this field.

So if you want to argue its POSSIBLE there will be questions? Sure I agree

If you want to argue its POSSIBLE for delays? Yes its possible, ~5% which is not 0

If you want to argue that its very likely there will be delays? Put up or shut up, because I can see no mechanism or grounds to support this which is why I firmly place it in the "Awe Stu has sold and is trying to trade and currenly out" camp, which if I am honest, gives me a little semi...

Side note, let me tell you how much satisfaction and joy it gives me to see you and Stu posting, seriously from the very bottom of my heart it is my desire that the pair of you are caught OUT of Hemogenyx as it re-rates up. And Seeing your posts gives me a warm glow thats hard to put into words, nobody would argue with such drivel and easily disproven nonsense unless they were feeling hot around the collar. So THANK YOU :-)

Oh right! your the expert then, so in the FDA presentation where they say its bad manners to submit on a Thursday or Friday they were lying and your the expert! Let me just email them to tell them the tractor dude from LSE says they are wrong :P

What gets me is these attempts to argue about fictional delays, am I missing something? Is this the same US FDA???

What are they reading that I am not?

May proceed after 30 days if not placed on Clinical Hold.

IND HAS been filed

Grounds for Clinical Hold do NOT extend to asking a few questions

95%+ success rate for those INDs that are filed.

This is NOT ramping or fanciful thinking, this is copy and paste from the US FDA and still they try and argue that black is white? Is anyone seriously going to believe 2 trolls over the US FDA's own website which again is right here:

https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-overview

To be honest I dont even know why your supporting "OR if it takes a little longer" because honestly I would not have a problem if that was the case but I cannot see any framework where by the FDA can delay the IND process other than clinical hold which would be a serious move. There is a reason why the FDA consider it "Bad manners" to submit an IND on a Thursday or Friday as it robs them of 3 calendar days (weekend) which they may need.

Do I know more than the scientists at Hemogenyx? No, do you?

Lets be clear about this, the FDA have an IND review process, there are lots of pretty flow charts if you prefer?

But the fundamental process is:

"Review Time for initial submission of an Investigational New Drug application is 30 days from the date FDA receives the IND. An IND applicant may proceed with a clinical investigation once the applicant has been notified by FDA that the investigation may proceed or after 30 days if the IND is not placed on Clinical Hold."

This is from the FDA WEBSITE. Its not from my backside or some fictional fairy land. THE US FDA, RIGHT HERE:

https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-applications-clinical-investigations-overview

Per records from the FDA ~95% of IND applications are accepted. The chance of a clinical hold is FIVE PERCENT.

This is not rocket science, attempts to confuse or deflect or inject doubt is irrelevant and pointless at this point because I am simply quoting from the FDA and Hemogenyx. The full line from the report says:

"We have been particularly concerned to cover all aspects in preparing the IND documentation so as to minimise any possible delays and questions that may arise from its review by the US Food and Drug Administration ("FDA")"

Well I bloody hope so!!! IF they took the extra time I would expect they used that time to minimise the risk of any possible delays and questions, IE that 5% risk.

I REPEAT, FROM THE FDA:

Review Time for initial submission of an Investigational New Drug application is 30 days from the date FDA receives the IND. (Which was 8th of May)

An IND applicant may proceed with a clinical investigation once the applicant has been notified by FDA that the investigation may proceed (Not going to put any hope on expecting this but would be a nice surprise)

or after 30 days if the IND is not placed on Clinical Hold. (Having a few minor questions is NOT GROUNDS FOR A CLINICAL HOLD):

https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-clinical-hold

There has to be an actual serious issue for a Clinical hold which would be SERIOUS and not just a short delay of a month or so.

From my point of view the probability of success of the IND is so high that in my mind Hemogenyx are now clinical, the fact the FDA have 30 days is just a very warm fuzzy feeling that we wont see the months of delay and silence we saw in the past. Knowing that its with the FDA and not with Vlad should also cause traders and trolls pause for concern, we are already 5 trading days in, there really is not that big a window to F about and safely get back in if you assume traders will want in before a presumed date, if the FDA announce sooner then so be it, happy days and excellent news for us.

Given its been a week and no RNS on the partner, going to assume they will wait for the IND application to be accepted so trials can start before putting pen to paper with Hemogenyx, meaning provided no clinical hold is applied we should be seeing an RNS on IND acceptance, official transition to clinical status and shortly after details of a large pharma who is going to run the trials which will be huge.

Not based on anything other than how I PERSONALLY would feel, IMO Vlad has been flat out with IND, it has occupied his time and its likely the past month or so he has focused on it to the exclusion of all other projects. When the IND period is over and trials can start I would expect he will want to focus and oversee the start of trials. IF it was me I would want to clear up as much noise before then as possible which would mean all those other projects that were going on in the background, CBR and CDX, where his team have never stopped work. He surely will want to tidy those up now while he is waiting so that he is not overwhelmed when trials start.

I would be very very surprised if we do not see updates on at least CBR if not CDX also in the coming weeks and then June I expect to be dominated by CAR-T.

Anyway, VERY excited about the next 1-2 months!

Go back and look at past significant RNS's, on the day bit of blue but underwhelming, few days of bears on the offensive with flat or even slightly red then... Back in Jan we did 100% over a few days

Everyone knows how I feel, a fair mCap for Hemogenyx as a clinical oncology pharma with CAR-T is north of 100m which represents 10p per share.

Its not yet clinical, that requires the FDA to accept the IND.... With a 95% acceptance rate IMO there is every chance.

For once also timing is NOT in the hands of Hemogenyx, its been filed, its with the FDA. Timelines are posted on their website here:

https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-overview

"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."

Tick Tock Mother F....

blastoid... yea, my **** has just been blistered by my boss for slacking off today..... i will take a break from posting for a few days :-p

I know your not buying, you already bought!

https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-overview

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 unless I am misunderstanding or am reading the wrong document either the FDA apply a clinical hold, or not and the vast majority of the time they do not. So how exactly do you arrive at August.

121..... I have some very very bad news for you.....

Notice how Stu has gone quiet? He is already buying back in, yes I know its sad he did not co-ordinate but hey, thats life!

Dont worry, I predict a bit of Friday FOMO tomorrow so if you set your alarm clock for 7:55 you can jump back in before it goes too high :P

Let me translate for you Chris:

one2one: "I have zero clue how options work"

Here for the science, yet at every turn take the opportunity to attack which is damaging to the company making it harder to raise funds and therefore harder to pay for the science you supposedly support, see why we have trouble believing you now?

Side note.... Its went blue... I genuinely expected this to repeat the trend of blueish day on RNS, 2 days of flat or slightly red then TOMORROW I was expecting the take off of a few days 10%+ rises. Ah well, if they want to get an early start so be it.

Well Peter, in 27 days according to the experts the market will have already "Priced in" the news. What will the news be?

That Hemogenyx is a Clinical stage Pharmaceutical company with a CAR-T treatment for AML which at that point will be deemed Phase1 and a back pipeline including CBR and CDX.

As investors or potential investors I and other want to invest knowing what that "Priced In" value is.

Some dont want us talking about that for their own reasons, IMO its entirely relevant to discuss what "Priced In" valuation is likely to be because it wont be 20m today, remain 20m for 26 days and on the 27th day we wake up to a new SP with not a clue what happened.

What is a FAIR market valuation for Hemogenyx when they are clinical?

What are the peers priced at?

People are fond of saying "Oh but its already priced in" when news does land but yet the price is exactly the same as it was a month before. So yes I am more than happy to wait 27 days, infact I will wait alot longer on CBR to get to trials but thats just me. But in the interm I want to call out the absurdity that people PRE news will claim a share wont move until news lands and when news does land will claim its already priced in.

For what its worth, I personally am not upset, I enjoy the back and forth with stu and 121, moreso when I am extremely confident and bullish like today.

You now have one2one trying to induce discourse and injecting some disturbing comments into a thread that contains valuations and posts relevant to the future of hemogenyx going clinical.

Want to know why? To hide those posts on page 2 OR better still to get his posts removed which usually means the entire thread gets removed along with any and all positive posts.

I looked a bit further into Autolus to see when they went clinical:

https://autolus.gcs-web.com/news-releases/news-release-details/autolus-therapeutics-announces-fda-acceptance-ind-application

Market capitalization was £110 million on February 16, 2020 which was a month before they filed the IND

Approval was 16th April when they were worth £150mil.

So thats a VERY similar candidate to HEMO-CAR-T much smaller pipeline, currently at £266million

So yes, they are further ahead than Hemogenyx, but I am comparing them LIKE FOR LIKE to hemogenyx, carving out ONLY HEMO-CAR-T matching them to Autolus at the point in time we are now, POST IND being filed and PRE acceptance by FDA when Autolus was in the band of £110 - £150 million. Compared to Hemongeyx which is ~£20mil but has much more in the pipeline.

121.... Thank you for proving my point :-) As clear as mud. Shocking how Stu arrives within seconds of you posting, I do not believe for one second your the same person, if that is the case then well done, well done indeed at maintaining 2 personas... Perhaps one messaged the other its time to get posting?

Saint, just one thing, on Autolus, yes your correct, Autolus did announce that on 8th December, SP has actually tanked a fair bit since then. Which opens up an interesting project... One which I do not have time right now to do but I will put it on my to-do list.

What was the market valuation of Pharma companies with CAR-T treatments before they went clinical and immediately after starting trials?

Not sure what happened to Marker Jonny, it was that, but looks to have tanked for some reason?

That said, I am very happy to see fact checking irrespective if its pointing out some of my data is old, THIS is what I want.

What is HEMOGENYX Worth today and once the FDA accept the IND?

What is CAR-T worth? What could it be licenced for?

This forum is and has been obsessed with whats happened in the past, what the SP was a year ago, past placings which were necessary as part of the R&D process. Lets start treating Hemogenyx like it is about to be classified "CLINICAL".

Whats it worth even at the start of the clinical process?

Are they really last to the table with HEMO-CAR-T? Are there other CAR-T treatments for AML I missed?

Who is the partner thats going to run the trial? What happens when the wider market starts to discuss Hemogenyx?

Anyway, ~95% its 27 days until clinical.... Tick Tock!