Member Info for JustHereForHemo

Irrelevant anyway at this point, dropped below placing, most short positions closed, Stu is "over-seas" which is code for "bought back in and wont troll for a while". The FDA worry was good for a whole half day but not related to hemogenyx, there are now no fears of placing for a few months atleast and the people who threw a hissy fit yesterday are starting to buy again. SP will recover, the trolling will stop and IMO IND WILL be submitted 2023 and FDA MIGHT approve this year.

Also, How are FAB going? Have you sold pumpkin?

Paying Prevail IS part of moving towards trials, and does not take weeks.

As for Testing, I Take it you are guessing HT? Making assumptions? Feel free to point me to the RNS that you use for evidence. All we know is Lentivirus remanufacturing was finished 16-20 days ago and a CAR-T production run takes 9 days with previously reported FULL end to end from production to testing being less than one month. And that was before the CH when nothing was signed off, before the FDA did their full report.

So in YOUR opinion they are weeks away. In MY opinion they are a few weeks away but it is possible next week or the week after. Which is fine, a few weeks is not unreasonable.

Sorry for pushing down page, Scroll down to post from HH in this thread, VERY good indicator of what IMO is likely to happen here.

Pumpkin, if you want to know what the money is for, a good bet would be a previous RNS:

"The subscription funds will in large part defray the payment made by the Company for the first stage of the work being undertaken by InfoWorks under the MSTA." Clearly more was owed to Prevail, rather than dip into the bank he has raised when opportunity arose. Also clearly states some of it is for CBR, so maybe wants to move it a little faster. He has always been prudent with the cash, if he thought it would take a long time he would have raised much more. Its 500k.... probably like 2 months cash burn, and he was offered more? That is not the sign of a delay, its a sign of a CEO taking what was on offer to pay some bills and leave a healthy bank balance to cover predicted runaway for the next 6 months.

If some of the cash WAS to pay Prevail that is a very good sign as that would indicate about ready to start the trials.

When your clinical funding is not an issue. Prevail will offer a good chunk however they are only one option and will only partially fund. There are charities that fund trials, grants, many many companies that lend, we expect the SP to be significantly higher at Phase 2 so placings when mCap is 200m+ etc is much less of an issue.

HOWEVER if you look at previous interviews to see Vlads intent, he has made it clear, prove it works and licence it, the money from licencing would then go to fund CBR. So whilst I believe he would have no problem raising funds to pay for trials I dont believe he will take it that far, IMO it will be licenced in Phase 1 after he proves it works, time will tell, either way is good.

Darwin, ALL opinions are welcome, HOWEVER the likes of myself and HH are willing to actually consider the news and ask questions, do some research and find out if it actually impacts Hemogenyx. And when we satisfied ourselves are willing to share and counter why we are satisfied that this is not bad news and MIGHT be good for Hemogenyx. On the other hand you have well basically stu saying "Wrong" with zero substance, context or justification. So how can you discuss or debate or have any sort of open exchange when the troll is interested in nothing other than FUD, has a clear agenda and point blank refuses to acknowledge that the very issue he chose to highlight was reported by the very people helping Hemo get CAR-T into the clinic!!!!

Stu, I think you will find like every industry CAR-T is maturing and every industry has its issues, would you accuse Tesla of having the same issues say VW had with their emissions scandal?

Would you blame apple for the same spyware fears attributed to Huwawi?

As is common, this issue IS genuine, it was highlighted from WITHIN The industry itself, by Carl June.

It was know BEFORE Hemogenyx went anywhere near the FDA

Carl June himself worked with Hemogenyx.

I agree the news WILL be long lasting and significant, I suspect for one or 2 products on the list they will be deprecated as first choice treatments when alternatives that dont suffer the same flaw come to market. I fully expect ALL these CAR-T companies to start answering "Does this affect you" And I fully expect Hemogenyx to be on the right side of the line. So as untasteful as it may sound? This will probably be good news for Hemogenyx.

Trying to argue that this will slow down or affect IND approval is laughable, the FDA did not just release this report having started it last week, this will be Months if not YEARS in the works. But lets see, time will tell, I would expect Vlad as CEO to address this publicly.

Separately.... There IS ZERO chance of you going away, MAYBE when you buy in you will change to another profile for a while, but nope. There is no off-grid any more, you will be here, lurking ready to post when you next do your trade. You will be here the rest of today, and unless you buy back in you will be here tomorrow... and the next day and the next. Posting or not your addicted to Hemo and cannot walk away.

Still think IND submission December, moreso now because of the small raise, IMO if there was a much bigger window the unpredictability of that window would have caused Vlad to accept all that was offered in the raise. He was offered alot more and took only 500k. While it surprised me he clearly just chose to take advantage of an un-related positive RNS on CBR, perhaps he expected SP to go much higher, maybe it would had he not chosen PeterHouse which is like throwing shares to traders and shorters to hit the SP.... But yea, still very much a 2023 submission for me.

Will he RNS? I dont know, hopefully, I did go over the CAR-T RNS's and have to agree with others he probably will as he has RNS'ed MOST CAR-T related events

Will the FDA approve quickly? No guarantee, but they approved the exit plan from CH, so they COULD take 30 days, I personally expect a response within 7-14 days.

So will Hemogenyx be clinical in 2023??? Very possible but tight!

Lol, Thanks Fonz, found on twitter:

https://pubmed.ncbi.nlm.nih.gov/30275568/

This issue was identified BY CARL JUNE 5 YEARS AGO!!!!!

Carl June of Penn!!! The same people that Hemogenyx had a master agreement with to develop HEMO-CAR-T!!!

At this point for me the chances of HEMO-CAR-T suffering the same problems is next to none HOWEVER clearly it DOES affect some treatments already approved. What does this mean???? HEMO-CAR-T I think works on various other cancers but only being tested on R/R AML right now? It may turn out to be more effective and SAFER than other treatments on the market and end up REPLACING them if the FDA does apply a hold to other treatments. So yes, the article is serious, but anyone who is idiotic enough to think that the FDA did not know about it when speaking to Hemo and thinks that Carl never mentioned it to Vlad does not deserve to be a shareholder here.

There is literally ZERO chance these FDA concerns came out of the blue in 24 hours, they will have known about this issue for months if not years. Anyone who thinks the FDA is going to continue handing out IND approvals without addressing these concerns is an idiot. I await some sort of statement from Vlad on this matter, I suggest people contact him and try and get some response, but there is literally no way on this earth the FDA would have responded to the CH lift plan positively if this issue they are investigating was a significant potential risk for HEMO-CAR-T.

Like I said however it was gift to Stu who likely had to readjust his trading plan, banking a profit off the CBR update, so be it, but seriously, the market reacted, those who were ACTUALLY affected suffered 2.5-5% hits..... whoopie.

Lets hope so soon Brendy, the usual attack of "placing" is gone, Vlad did not raise anywhere near enough to indicate any sort of delay and shorters who would tend to lead the attack when trolling etc have greatly reduced their positions. All of which point to less trolling (except stu, he is back and will hang around until he buys again), less fear and more confidence. It will bounce, I have zero doubt, just lots of people losing their rag for one day over an unexpected placing because they didnt sell yesterday at 20% and buy back today. All those emotions will disappear pretty quickly when SP starts to climb again, been here long enough to know that sentiment here changes faster than the daily news cycle in the US.

He was setting Hemo up for a trade with anticipating no RNS for IND by end of month, but the FDA CAR-T article was a bit of a gifthorse to trade on so cant really blame the chap. However rather than just dismiss it out of hand I decided to share some actual research.

1, Companies affected include: Gilead whos shares were down marginally, Legend's stock fell 2.5% to 11bn. Autolus Therapeutics, which is also developing CAR-T therapies, down nearly 5% to 800m so yea companies with licenced products had a whopping drop.....

2, RBC analysts in a note said the concerns could be higher for Novartis' Kymriah, and extremely rare for all the other marketed CAR-Ts. Kymriah is a CD19-directed genetically modified autologous T cell. The FDA is investigating the reports amongst patients who received BCMA- or CD19-directed CAR-T cell immunotherapies. Hemogenyx are targeting FLT3, this is NOT the target of this investigation.

3, Benefits outweigh the potential risk, with rates reported looking very low (early days but I saw figures of 0.5%) its better to risk cancer down the line than to not get CAR-T even if it is CD19.... FDA recommendation is "Patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies." They are NOT placing a clinical hold, they are NOT stopping treating patients and they are NOT stopping new approvals.

4, This is the result of an FDA investigation with future investigation to be done, it did not materialise today, when the FDA applied their clinical hold it was not done in a vacuum as such it MAY have been a side effect of this investigation. Likewise when the CH lift plan was lifted recently they would already be investigating this issue, potentially this could put Hemo AHEAD of existing treatments where there is risk which Hemo not yet in trials was forced to mitigate.

5, Here : https://www.sciencedirect.com/science/article/pii/S2329050121000280 is interesting reading, I cannot find details on the issue with Kymriah however a study showed malignancy caused by unintentional transduction of residual malignant B cells (CAR-B cells) presented on the surface of lentiviral vectors. And what was the cause of the clinical hold here?

Bottom line is, despite fear mongering from Stu, the leaders in this field suffered a mere 2.5%-5% dip on this news, the impact is quite low and IF it were applicable to HEMO-CAR-T of all companies, the ones on CH actively communicating with the FDA would be first to be told to make changes. HH called out the emphasis being placed on EoM for an IND RNS, but honestly, this WAS a gift to him, most of this board can hardly read and the majority of those will never bother to do any actual research.

https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-investigating-serious-risk-t-cell-malignancy-following-bcma-directed-or-cd19-directed-autologous

I saw it earlier and had a look, and as I said at this time not related to FLT3. In addition even they made it clear that the benefits outweigh the risks. Will it mean further regulation with life long monitoring and blood tests for patients? Who knows. Not great for the companies named but it's not the end of the world for them and right now not related to Hemogenyx. I agree it may cause the FDA to demand more stringent clinical trials but beyond that? When I first saw it my first reaction was several of these treatments target AML, so this is good news for hemo,but that felt distasteful to say.

"in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies" so no. Different target.

I'm perfectly comfortable with my investment and given how large it is for me that's saying something. Unlike others on here I don't feel the need to trade or wet my pants when vlad raises 500k. Guess we are getting close to the end, either I'm right and we go clinical and I'm retiring early or not. All I see today is a dose of emotional traders acting like vlad personally offended them and trading on their feelings, work away, I'm here to get rich supporting a good company. What's the bet we bounce hard tomorrow, its not like people can use threat of placing any more.

There is another delayed 1.4m buy

So be it, people who waited for a placing got in cheap.

I said before vlad probably would take advantage of a significant rise in sp, I was surprised it was so low.

As for changes in short, 7% dropped to 3% on ig.com

And spredex dropped from 19% to 9%. Not completely closed but a very good indicator

Jez not happy no,but nor was I happy with the level of short positions or people insisting there was going to be a big discount placing. From what I can see it's a small placing, clearly enough for IND and start of phase 1 and shorts are gone. So ecstatic? Nope. But on balance of positive v negative in a better position today

Small placing, standard discount, large after hours buy, shorts closed.

If you sold, cya! Not wasting anymore time on this piddly insignificant raise. See what the market says in the days and weeks ahead

Shorts gone long..... Just checked most of the short positions have gone long.

Bottom line is, plenty of traders and shorters expected a placing, were betting on a placing and were actively working to keep SP down hoping that would happen. Its happened, they have closed. Well done traders, small profit off the back of a company looking to cure cancer, hope you feel good. Now please just go away and dont actually invest.