Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Asleep - if you agree a plan with the FDA and successfully test the solution and resubmit I think that should put us in your 10% (even if that was a reliable source). The FDA can't set Hemo in motion on a half-baked plan and then come up with something else to hold it back.
I don't know about anyone else but I am on tenterhooks. The CH lift predictions suggested a more swift response and even though I am just 1 day and a bit from my own prediction, I am a little surprised that the FDA haven't turned this around within the last week or so. I maintain comfort in the fact that whilst it was not a quick "yes", it wasn't a quick "no" either. In addition, how many times have you asked someone for feedback on a proposal several weeks in and the response is typically "Oh I will get a look at that in the next day or so, promise!"... perhaps this resubmission is one they are not too worried about (they have agreed a plan) and will actually deal with it within the last 15 days not the first 15. . GLA
7th Feb for RNS? Ribbit & me in the hot seat for tomorrow. In addition, it's a Wednesday, which statistically is a good day for official news - did I ever tell you that HT? Let's hope so for everyone, another weekend to wait through is a hard slog, albeit Hulver very kindly kept us going through much of the last weekend with some valuable information. GLA
Pk if I was the FDA and had issues a letter giving IND approval and then got a call to say can you confirm verbally I would probably say "read the bl**dy letter and stop wasting my time". However I get your point but for a simple delay of 24h, ie getting the IND the day before the 7th would
be pretty damn lucky for Hemo if that was their strategy. History tells me Hemo have not ridden a wave of luck but rather grinding toil and sweat to get where are today. Time I guess will tell. GLA
Thank you Hulver. Next week I hope we get the mother of all RNS's we are ll waiting for and that we do not go down to the wire, with all the doubt that may fuel. Its gonna be a long weekend for sure. Off to get my eyes tested, I keep seeing red dots. GLA
Today was an encouraging day - small steps and consolidation is good. Shareholders, like me, gripping on for dear life to those we have bought. Let's keep it that way on the run in if you can peeps. Surprised it has taken this long even though I estimated the 7th Feb, but picked that date as the FDA are giving the go ahead to inject people and there has to be ar8e covering by someone. That means internal FDA due diligence, undoubtedly a staged process. This is a huge step and the rise in share price should duly reflect that transition, or as often said, the inflection point. Unlike the first time submission when the CH came relatively quickly - not so with the response to this resubmission. I think if there was an issue with the one thing that Hemo had to get right against the background of a plan approved by the FDA, then it would have been easy to spot to identify & respond to. That has not happened! As I say, it's the internal due diligence and sign-off which is holding this baby up. GLA
In my view the RNS is already written, like most "press like" announcements, these are not created on the hoof. Hemo will know already and will have crafted what they want to convey. It's simmering away (in the words of Tilly), it's precious meat and cannot be re-heated and just needs the SEND button pressed when it comes to the boil. So, literally the RNS could come any second of any day. GLA
Morning all, I have the 7th Feb for an RNS and I hope I am wrong. However, today, Monday, has not yet ended. It is very well worth noting that the CH RNS landed at 11.24 AM on 2nd June 2023, a Friday.
So, I would say that the CH was of a stature which required a more or less immediate RNS which you could say that was. That is, 11 am New York time is our 7 AM RNS time. So, giving Hemo 24 minutes to write the RNS for the CH they dropped it to us on a Friday at 11.24 AM. Might the going clinical approval happen within minutes or anytime today, DEFINITELY a YES. The lifting of CH will be an immediate RNS - no carry over to next day just like the hold. GLA
Simon, if you have been sucking up all that Helium - squeaky voice time for you then. If there is "life outside Hemo" perhaps you might stay there rather than coming here and being so obnoxious. Completely unnecessary. Have a good weekend all.
The FDA will not wait the 30 days to tell us if the CH remains in place is my understanding from reading about complete (CR) responses to CH's, as this is the first thing the FDA need to determine and they would have discussed this by emails or on the phone by now. They initially determine the question, has it dealt with all aspects of the reason for the CH (Are there any elements missing from the required resubmission?). Since we only had one issue and a plan to address the CH which was accepted by the FDA, we would have known by now if it was not a CR at the very least. The next step for the FDA is to get the resubmission reviewed to assess the quality of that response . Once again, this should not take too long because Hemo and FDA both knew what the answer should be to clear CH.
However, the days for a response, although diminishing, in this case, no news is not bad news. I think, for the reasons above, if there was a problem with the response we would know of it by now. However, as well as this, the FDA have to carry out their own due diligence and sign off, so getting people around a table to do that can be a time drag as many of us might know ourselves.
In summary, whilst I would have loved the CH lift dates from the early date guessers to be right, it is absolutely no indicator of the ability of this resubmission to get through. It's a hard wait all the same GLA
Vlad has done a number of teasing posts and they have some merit in suggesting things are moving a forward direction, especially those lab related as this one is. He certainly doesn't look too worried about anything. He's already literally gearing up for the next phase CBR so finance may soon be in play. If things were crumbling around me that last thing I'd want is a photo shoot. Good finds guys GLA
Glad to see VLad saving money. Those Tyvek suits are from DuPont and can be bought for around £10 or less and even on Amazon. Just hope they arecnot a job lot from that Mone chancer. I also believe Elon is recruiting astronauts. Don't go yet Vlad an RNS incoming. GLA
If there was evidence then the FDA would ground use. In the end if there is a problem it will be the Biotech firms which find it, not the FDA. Until then many are being cured when there are few life-longing alternatives. If they are not grounding those who currently administer Cart T therapies, then how can they possibly maintain a CH on Hemo - what, for something that might or might not be happening with someone else's therapy. Imagine - FDA "Oh, we are not sure about all these CAR T therapies but we'll let them carry on treating patients and take it out on Hemo by maintaining CH". It ain't gonna happen. Don't let yourselves get spooked. GLA