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Max
Day One received rare paediatric drug designation in June 2021, when they were enrolling for phase 2. That could mean we are at least 3 years behind them. However, hopefully the EAP would shorten that. They still appear to need to complete phase 3. An updated timeline from IB would really help investors understand where we currently stand in my opinion. Hopefully not much longer before we get the annual results. Thanks for finding the information. Here is a link to their RPD result:
https://ir.dayonebio.com/news-releases/news-release-details/day-one-receives-fda-rare-pediatric-disease-designation-day101
Thanks once again
Kane
I totally get people’s frustrations and I have only been invested for a few years. But my reading of the GaM trial is we seem to be being led by the FDA who seem desperate for it to work. All of that is outside the Board’s control. That is KS and MS doing what they are currently doing. I think somebody said after the latest shenanigans that they had spoke to Mike and he said he just gets on with the IB business. That is what we want him and the team to do. Somewhere at all the conferences somebody will eventually say we want that drug and or the image technology. At that point then it will be up to the board to get the best price available. We all know the share bears no correlation to the value of the company. We now have more universities using IB technology for their trials. Again this can only spread the word to other hospitals etc. The only way the board can make serious money is at some point to sell the whole company or IB. We all hoped it would be the PRD and subsequent voucher acting as the catalyst but that hasn’t occurred yet. But we do know that has a deadline of 2026.
Frustrating, annoying etc but IB keep moving forward.
Hopefully we get some indication of the short/medium range future either this week or next.
Thanks
BB
Thinking about this scenario
If it does keep happening which others have suggested as well then maybe we should all be doing the same so as to increase share holding for the same valuation.
I personally will not be doing that because I believe we will get a transformational RNS out of the blue and I don’t want to miss out on that chance. We all have to do what we think is the best for ourselves whilst IB does what is best for the patients.
In IB (and the science) I trust.
Thanks
Max
Hopefully news this week but who knows?
So what do we want to hear:
•PRD approved and the company say what is the next step to getting a the voucher.
•EAP up and running
•Zero been resubmitted
•CPT been resubmitted
•GEHC and Catanic sales far exceed expectations
•Grant from Gates Foundation
•Bayer want to buy the company
•Big pharma wants to co-sponsor the trials
Any of those would be positive
Or is it more likely:
•No sales via GEHC etc
•Current partners haven’t renewed their contracts
•KS lab is looking for a new partner
•New fund raise
•PRD has been rejected
All possible
Or
• No news, just the basic accounts and a few special proposals for the AGM.
•new research by crystal and announcement the company shares should be worth 8p so the board will buy ours back for 2p and say we are making 30% on current sp.
Fingers crossed everybody. We should know in the next week or two the short term direction of the company.
Thanks
Max
Looking at the last week’s trades it does look like 1.57+ are buys and anything around 1.50 are sells. But once again we just don’t know.
Xviolet
If you read the January newsletter (bottom paragraph) we may not have even submitted the revised CPT yet. So I think it may be late this year or early next before we get a code unfortunately. So again we have no idea about revenue.
Thanks
Max
I doesn’t look like we were mentioned but no actual video or transcript.
https://cloud.withgoogle.com/next/session-library?filters=track-ai-and-ml&demo=SCT-AI1#all
Totally agree about Zero, it is about time we heard about the resubmission. It seems to have gone very quiet on announcements at the moment. Maybe a blockbuster announcement with the yearly results? We can all dream.
Thanks
Cautious
Totally agree we are at this sp due to all the shenanigans but what I am trying to say is there must be an exit strategy by TB and no way is that at this valuation. He must know more about what is in the pipeline. As I keep saying this company must be or will be on bigger fish’s radar. TB is looking at a paper loss of £10m from what was the high point of 20p+. I think we have to be looking at a figure above that for him to sell.
Regarding KS and her involvement in other trials. It doesn’t mention IB but I would guess that they are using our technology for the imagery. The more other universities use our technology the better. Keep spreading the word etc.
Thanks
It is 2 months since the last update. So the question is will TB want some good news published before the yearly results or the AGM? It will be interesting how he conveys what has happened to the share price after saying last year it was way undervalued and would try to improve upon it. Would he admit he has failed or will he try to increase the sp before then? Let’s see what happens over the next few weeks or month.
Thanks
Morning
If we say TB and family have always controlled 30% approximately of the company then they:
Currently own £1m of stock
January 2024 owned £3m of stock
November 2020 high they owned £11m of stock
So you could say they have a paper loss of £10m. Have they sold the company, no. Have they stayed at around 30% holding, yes. Have they taken it private, no.
Has the company’s technology improved in 3 years, I would say most definitely.
This is where we all have to make our own judgment call. Do we believe in the technology or are we worried about TB’s shenanigans? If he is so financially astute why didn’t he sell in November 2020. We keep saying he knows far more about what is happening behind the scenes than we do. We also know he said previously he would be judged by the share price within 2 years.
I am not trying to be TB’s biggest fan but looking at this logically something must be in the pipeline to keep him interested. So as I see it people can jump ship at a possible loss or we can sit it out for a bit longer and see where this goes. How long, I don’t know? However, I do believe in all the great work KS and her team are doing. That is what I am invested in.
Personally I am nursing a considerable loss and I hate all the shenanigans that are happening but “in IB I trust” and like a few others will stick around until “the end”.
Just my Friday ramblings, have a good weekend everybody.
Thanks
More progress on MRI scans
https://apple.news/AoK71NEeqTkeqUICCUtt_ug
Thanks
Dear all just found this update
If we get the PRD designation it looks like we have until 2026 to get approved so we can get the voucher. As always this is my reading of this totally confusing procedure.
“2024 update: Rare Pediatric Disease PRV program sunset
Under the current provisions in the law, the rare pediatric disease PRV program will begin to sunset after September 30, 2024. Section 529(b)(5) of the Federal Food, Drug, and Cosmetic Act states:
(5) TERMINATION OF AUTHORITY.—The Secretary may not award any priority review vouchers [. . .] after September 30, 2024, unless the rare pediatric disease product application—
(A) is for a drug that, not later than September 30, 2024, is designated [. . .] as a drug for a rare pediatric disease; and
(B) is, not later than September 30, 2026, approved under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act.”
Come on Mike give us some good news we are all desperate for.
Thanks