Adam Davidson, CEO of Trident Royalties, discusses offtake milestones and catalysts to boost FY24. Watch the video here.
Thanks BB
Where did this come from if you don’t mind me asking?
The last paragraph on page 1 is the one I am most interested in regarding the trial. So hopefully a decision in February. However, the bit about PRV still leaves me confused as to when we can get a voucher if eligible as it says when GaM is FDA approved. Surely that would be after phase 3 or am I missing something?
Anyway great news. Let’s see how the markets react tomorrow.
Thanks
This article may be of interest to people regarding the PRV, it is 3 years old but I assume still relevant
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7877854/#:~:text=The%20first%20PRV%20was%20granted,in%20the%20last%205%20years.&text=Number%20and%20types%20of%20priority,(FY)2009–2019.
However, this bit jumped out at me
“For instance, the average annual pricing of drugs approved under the Orphan Drug programs was reported to be over US $180,000 in 2018. 7 Many of the drugs granted rare pediatric disease PRVs are reportedly priced considerably higher than that, with the highest price reported for a drug granted a PRV of ~ $2.1 million (a gene therapy for spinal muscular atrophy, albeit this is a one‐time administration). 8 Although the GAO report does not delve into ultimate pricing of products granted PRVs, it is important to consider if PRVs are still needed in driving development, particularly in rare pediatric diseases. Notably, the report cites discussions with seven sponsors granted PRVs. These sponsors reported that whereas PRVs were a factor in development decisions, only one sponsor reported that the prospect of a PRV was a primary factor in moving a drug into pediatric development.”
$180000pa and with extended exclusivity via the orphan drug designation. I can’t even imagine what the total income over the period of exclusivity would be.
A long way away I know but that could possibly be the ultimate result. We could all club together and buy Neckar!
Have a good rest of the day.
Thanks
Xviolet
It is the IB team who I believe in. Their expertise and wanting to research new ways of helping people is beyond reproach.
The IQAI side I am not sure where I stand. Too many guesses at what is happening. However, if TB sees the vast potential in this and backed it with his own money I have no issue with that.
Mike and the team just seem to deliver every time they set out to do things. Again I agree we seem to be helped massively by the FDA and I can’t see them doing that unless they see there is a big chance this can help people who suffer from GBM. All the snippets we hear are about how this helps those patients which I personally think is fantastic. Somewhere down the line we are going to wake up (or mid afternoon) to find an RNS that says we have entered into a joint venture or been taken over by a big pharmaceutical company. When, I have no idea that’s what makes it interesting and at the same time frustrating.
Thanks
Dear Howdlep
We have no control of what TB and his family are doing with his shareholding and any alleged manipulation. I am sure he doesn’t care an iota about this or any other bulletin board.
I think BB’s email comment from TB saying shareholders will judge me over the next 2 years is more important.
We can all get upset about the share price dropping but this only affects those people wanting to sell now. I would imagine most long term holders see the huge potential of IB and its products and have no intention of selling until this potential comes to fruition.
Yes it looks like we may had made a paper loss but I for one am more interested in the actual profit we could achieve. What could the sp achieve, I honestly don’t know and I keep reminding myself TB didn’t sell at 20p so why would he sell for anything less now when we have in the pipeline a potential massive windfall from the GAM drug, plus all the IB imaging products. If this technology can be proved to be used on other cancers, such as the recent grants awards seem to suggest they may be looking into, as well, then after meeting up in Wisconsin for Christmas dinner we can all fly to Neckar to continue the party.
Short term pain for long term gain.
We just need to be patient, and all of us including myself become frustrated at times, and see how this plays out in the medium to long term.
Have a good rest of the weekend everybody
Thanks
Just rereading this post from Max.
Priority review voucher
“The term "priority review voucher" means a voucher issued by the Secretary to the sponsor of a rare pediatric disease product application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] after the date of approval of the rare pediatric disease product application.
The Secretary shall award a priority review voucher to the sponsor of a rare pediatric disease product application upon approval by the Secretary of such rare pediatric disease product application.”
I am now thinking I have been wrong about when we can apply for the voucher. Reading this I am now believing when they say drug approval it is not passing phase 3 approval. It is when they get rare paediatric drug approval. I do hope so. In which case we just need the update of whether or not it has been approved asap.
Also if it hasn’t been approved then if TB and family are doing all the selling wouldnt that be inside trading. I can’t see that happening especially if you tie it in with BB’s email.
We just need an RNS to confirm one way or the other. Let’s not forget the USA is 5 hours behind us at least, 6 in Wisconsin.
Thanks
BB
Thanks for the info. It would be nice if TB could be more communicative with shareholders at times. It seems to be all from Mike with a little comment from TB at the end.
What is interesting is his use of the next couple of years that suggests to me he is in this for the long term, no selling of the company etc. Does that tend to imply he is looking more at a joint venture and a prolonged period of growth rather than here is x amount for the company.
Frustrating but intriguing.
Thanks
To pick up on something Trek mentions in his his post. This all does seem very rushed and hasty. Is there something happening behind the scenes we don’t know about.
Have a good weekend everybody, don’t book the flights to Wisconsin for Christmas just yet.
Thanks
Seems a bit manic buying/selling and here this afternoon.
•Yes we have delisted from USA
•Newsletter is NOT the shareholder letter, which should come via a RNS
•IB are still doing all the great work and moving forward
•Share-dealing, could this be the missing 1% from TBs 30%, he is picking up cheap maybe. We honestly don’t know.
•SP if you believe in the company and its products, that is IB, then if you have money it could end being a bargain paying just over 3p a share. That is the risk we all take.
•Can we do anything about all this? No we unfortunately just have to sit and wait.
Hopefully news and a better day tomorrow.
Thanks
Howdlep
How do you know we are not getting a shareholder letter as well? Have they actually stated that somewhere?
Just a bit confused as to what is happening. Newsletters and shareholder letters are totally separate to each other.
Thanks
Xviolet
We already are gaining sales via GE Healthcare and Bayer for the IB products. We unfortunately don’t know how much yet until we get our update/accounts.
If I remember correctly aren’t we waiting for a CPT coding to make easier for hospitals to charge insurance companies for using our technology in scans? An update on that would good as that would surely increase our sales.
Hopefully now all CLNs are sorted partnerships and joint ventures could be next. However, we have achieved all of this with grants and we are waiting for the update on the new grant we are hopefully submitting in February.
We just need to keep patient, IB keeps delivering and seemingly is being guided by the FDA who must see something they like. IQAI have sorted out the share issues. What isn’t there to like?
Thanks
Letter to shareholders due
Paediatric rare drug application due
Hopefully then an update on the voucher process
The new possible grant application update, I think Mike said February for this
IB Zero possible application
Plus anything else we aren’t aware of yet
I would say that is quite a few positive things we could hear about in the next month.
Fingers crossed
Thanks
So hopefully any positive news means the sp should increase from now on.
Interesting that TB and family only hold 28.6% not 29.9%. I wonder if somebody else in the family has bought the other 1%.
Fingers crossed the market now starts treating up more positively given all the great news we have had recently and all the things still in the pipeline for the near future.
Thanks