Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves as "we", "us", "our". The user of the website is referred to as "you" and "your".
By posting on our share chat boards you are agreeing to the following:
The IP address of all posts is recorded to aid in enforcing these conditions. As a user you agree to any information you have entered being stored in a database. You agree that we have the right to remove, edit, move or close any topic or board at any time should we see fit. You agree that we have the right to remove any post without notice. You agree that we have the right to suspend your account without notice.
Please note some users may not behave properly and may post content that is misleading, untrue or offensive.
It is not possible for us to fully monitor all content all of the time but where we have actually received notice of any content that is potentially misleading, untrue, offensive, unlawful, infringes third party rights or is potentially in breach of these terms and conditions, then we will review such content, decide whether to remove it from this website and act accordingly.
Premium Members are members that have a premium subscription with London South East. You can subscribe here.
London South East does not endorse such members, and posts should not be construed as advice and represent the opinions of the authors, not those of London South East Ltd, or its affiliates.
Looks like a mistake it was cancelled immediately.
Feeling better today nice blue day on 3 of my shares;What's with the 1 .5 million sell?
HFH -> :-)
Barber, this is all new stuff, I am not saying its likely but alot of drugs fail at Phase 3, if Hemo has hit a decent valuation before it gets anywhere near there then you have to de-risk. Well I say that but it does depend I guess on what Vlad says, if he makes it abundantly clear he is not going to do Phase 3 and wants to sell/licence then might as well hold for that. Lets see what happens, not even remotely close to a level I think where anyone would consider slicing :P
Brewsky JHFH Thx for the responses. I’m feeling a lot more confident things could happen sooner than I thought, here’s hoping anyway. In the meantime I’ll try to keep my frustration in check lol.
Thanks for the response JHFH, I was looking to hold here until outcome of phase 2 as it seems a good balance of time/payoff.
Have been in Verona Pharma for what seems like an eternity and they are now at the stage where they'll report the outcome of two stage three trials this year, and go for NDA if results are good.
Just don't see the point of waiting for stage 3 here unless there are better timescales.
Better to read what the experts say about valuations, there are multiple but this is one of the clearest examples I have found for valuation:
https://www.toptal.com/finance/valuation/biotech-valuation
Put simply there are many stages, Pre-Clinical -> Phase 1 -> Phase 2 -> Phase 3 -> NDA.
The chance of failure at any stages is quite high, but the highest failure is in Pre-Clinical when probably half of candidates will fail. So when people value biotech companies they have to offset the risk against the potential market. Therefore you need to know the target market, the competition, the potential value if the candidate is sold and the discount rate at each stage.
IND is that border between Pre-clinical and Phase 1, the discount at pre-clinical is massive, the discount at Phase 1 is massive, its not until phase 3 when you start to see real value. HOWEVER even the discounted rate at phase 1 is massively higher than todays mCap, here is another link: https://www.baybridgebio.com/drug_valuation.html
Value at start of program $0M
Probability of FDA approval: 4%
Value at start of Phase 1 $88M
Probability of FDA approval: 12%
Value at start of Phase 2 $248M
Probability of FDA approval: 20%
Value at start of Phase 3 $1,119M
Probability of FDA approval: 56%
In terms of IQAI I cant find anything in terms of market for them, from what I can see the IND was just for a different capsule? That is Vs Hemo which have a CAR-T candidate for oncology, where many of the existing treatments are ~$500k per patient the markets are not comparable.
I would also say because of the nature of CAR-T/CDX and the target they are treating they have stated they are probably doing Phase 1/2a as its not safe to administer either to healthy patients for a traditional Phase 1 trial. I dont know where that puts hemo in the graph but certainly a lot higher than 16mil.
Any sort of discussion or arguments about the share price or mCap today is pointless, its based on a pre clinical pharma that has been decimated by CLNs. Nobody in the pharma world is talking about hemo yet, nobody doing valuations yet, they are not clinical. Worrying about a 2%, 5%, 10%, 20% gain or fall here is pointless because none of the big players who matter have even bothered looking yet. When we go clinical we will see what people really thing about Hemo.
IQAI have IND, not a whimper!
But then stocks don’t behave the same. I would expect a relief rally here that will likely be sold into as before but longer term I see this picking up strongly.
Usual caveats
Trek
There was a lot of talk in the past of a rerate when IND application went in, mostly from Pingu so for the most point I just disregarded this.
Are people still expecting this to spike upwards on IND approval?
Was thinking the SP would be subdued until positive trial results...
There isn’t enough volume for a rerate. Either of the last couple of RNS’s could have been a catalyst but it fizzled out on lack of volume.
I recently bought back the ones I sold at 2p. Keeping a core though. I just find it helps to average in slice and recycle until it takes off.
Usual caveats
Trek
It would be foolish to rely on anything Vlad said 6 months ago to try and second guess when any clinical trials will start. He also said they would be asking for a meeting with the FDA early in the new year where in fact he actually asked the FDA over a month ago in December and the meeting could very well already have happened or if not it should be in the coming week or so. IMO the IND application is about ready to go and the Wu-Xi RNS was one of the final steps required, their commitment to accelerate is great to see. Someone on here said they had been in comms with Vlad a while ago and he was in Maryland doing a test run of the CAR-T I believe? It just does not feel like there is much standing between now and IND application, why would you be doing a test run if you still have any testing to do?
As for when the IND submission will actually be... None of us can say with any level of confidence. Thats what the pre-IND is all about. The FDA could say they are happy and go ahead and file, or they could ask for something additional, they could fast track or they could shut it down. Vlad didnt know 6 months ago what the FDA would say, if he did there would be little point in having a PIND. IND could be weeks, could be months, could be never, it all hangs on the FDA.
Incase there is anyone left who is not yet aware I am 100% in the full confidence bullish camp and even though already at 100% my confidence grows with every RNS. I think the FDA will be happy and Vlad will move swiftly to file IND application. Purely as a guess I think March for IND application and May/June for start of Phase 1/2a CAR-T trials with a CBR update before either happens.
#LetsGoHemo! #InVladWeTrust
The timescales were laid out back in October.
IND submission for CAR-T in the Summer, then HEMO has to wait 30 days before commencing the trial, so clinical trials probably also starting in the Summer.
@HereforHemo
1, I dont know I would like this also.
2, Per the FDA website, you get one opportunity to ask for a Pre-IND meeting, dont waste it, there is nothing to imply that Dr Sandler has to pass some sort of test before being granted a meeting and within 60 days. There is therefore nothing meaningful to update the market with which would justify paying for an RNS.
3, "PIND meetings take place only when a developer is commencing the design of a clinical trial in the US." Hemogenyx would not be applying for PIND or filing IND if they had not completed pre-clinical studies. However there is the possibility that the FDA could request additional pre-clinical studies as part of the PIND so any such definitive statement before the meeting would be counter productive.
4, I thought the statement was starting clinical trials towards the end of the summer, not filing IND, but I cannot find the source so cannot confirm. What I have seen is multiple RNS's which contain statements like the following:
"The agreement is key to advancing our HEMO-CAR-T programme into clinical trials and accelerating the timeline to deliver this innovative therapy to patients in need of a more benign and effective treatment for AML". "Accelerating the timeline" sounds like they want to accelerate the timeline.
Strange I’m meant to be selling when I’ve only recently topped up lol. You ask what I’d like Vlad to tell me, well four things really.
1. Where’s the CBR update that he promised was ‘soon’ back in June?
2. Did the FDA agree to the pre-IND meeting and if so when is it?
3. People like yourself are saying pre-clinical work is complete and clinical trials are soon, yet you stated that when you have the pre-IND meeting CAR-T would be 80% complete. Is this no longer the case, are pre-clinical studies complete?
4. You stated a CAR-T IND application would be made ‘in the summer’. Has this now been brought forward because that’s months away and would indicate people are selling if they mentioned it so can you clarify?
Don’t think that’s too much to ask, do you?
Hi All,
Steady the ship! Just look at the recent RNS announcements:-
2nd Sept 2021- US Patent Approval - monoclonal antibodies for CDX & Hemo CAR T treatments
13th Dec 2021 - Pre-IND meeting request CAR T , then just 7 days later
20th Dec 2021 CAR T Partnership with WuXI - confident enough to sign a partnership deal with WuXI just 7 days into Pre-IND meeting request - did they receive early positives to encourage the WuXI Agreement signing.
12th Jan 2022 Selexis Partnership announcement re CDX
What's not to like! When you set sail with this share you saw the destination, it's in sight . So, don't drift, stay the course and beware of pirates seeking to steal your shares or cause a mutiny . GLA
Not a great day, but positive returns elsewhere have been nice, @HereforHemo what exactly would you like Vlad to tell you that you would expect from any other CEO? I have researched the PreIND process and as others have said its 60 days, there was an RNS to say it has been requested, until it happens there is nothing of a price sensitive nature to be announced. In the past 2 months we have had 5 updates, 3 of which I consider significant. Dr Sandler is running this company like a CEO should, professionally and moving quickly to advance to clinical trials and providing updates as and when it is appropriate to do so. @MrIndia if you want to know who is selling in particular probably good idea to check out these boards for people who are advising others to take a loss and move on or saying "hear nothing for months". Also worth looking on twitter for posters who go from multiple posts about hemo in a day to zero.
Mr India in answer to your questions, imo people are selling as Vlad is still running this like it’s a private company, in stealth mode telling investors nothing.
And although investors expect an update on the FDA meeting there are no guarantees. It’s quite possible we hear nothing for months, certainly based on previous HEMO experience. So if you need the money or think something will move sooner, just take the loss and move on. Else wait it out like everyone else.
Mr India, I think the issue many have with you is your basing pretty much your entire reaction on the SP. The fact is that some traders who like to play the swing on a tiny company and are able to pocket a few % here and there with relatively little capital. But as annoying as the SP is it has absolutely FA Squared to do with the company or whats happening behind the scenes.I am wasting time and space having a stupid back and forth with you about SP when its a complete waste of all our times. Either we go clinical and save some lives and Hemo is suddenly worth many multiples of today or the FDA slam the company and we are up the creek, or worse still we start clinical trials and vlad kills a few bods. I am not saying Hemo is a binary play, but what I am saying is worrying about a 1-2% swing in the SP when the mCap is 16mil is a complete and utter waste of time. If you want to carry on being worried about the SP and who is selling then work away, I am sure you will make the traders very happy. I am off swimming with the kids.
We are all suffering but i got into this with my eyes open so am hopefull for turn around for all of us mrindia sit back grab a beer and chill all will come good
You really need to get those tablets sorted out mr knowitall
Well said Bline59
Bline59 ... what is the use of this board if you cannot express your sentiments. We cant always just paint a rosy picture when it is not. Thats called pumping
Mr India.
All LTH's are disappointed in the SP, but it will come good, however I am going to be a blunt Northerner, please either Sell, or Shut Up and wait like the rest of us.
Or maybe mrdepressing is still here JHFH is because you have stated SP will be ten times higher when we start clinical trials ?
Here are my issues :-
- Why are people selling so close to IND. It doesnt make sense and it cant be because they need the money surely.
- Will we definately knoew the results of the FDA meeting or will VLAD not update anyone and this will linger on for months
I am getting to the point where i have been here for over 18 months and need the money. I know the upside but we keep making excuses for this stock while others recover. This is heavily manipulated by sellers and hard to stay positive based on history. Sorry for my negativity but I am entitled to my view