focusIR May 2024 Investor Webinar: Blue Whale, Kavango, Taseko Mines & CQS Natural Resources. Catch up with the webinar here.
If they make us all multimillionaires then we could fly to Wisconsin and celebrate with all the IB staff.
No pressure Mike, all we need is that one RNS to make the sp pounds not pennies!
We can all dream. Hopefully we will know sooner rather than later if beans or a 5 course meal.
Thanks
Max/Shrek
Let’s hope so but I imagine the Christmas break may have added to the 60 days
Whatever we should know sooner rather than later and I hope Mike clears up the confusion about the PRV and gives us an approximate date for that to be applied for. In my opinion it is that which they dramatically increase the sp.
Fingers crossed
Thanks
Morning Maximillion
Thank you
I did work out the total holding is based on the sp but then they show a daily gain for individual stocks which must be using the mid price. HL seems to be confusing people by using different values for different measurements
Total holding via selling price
Daily increase via mid price
Thanks anyway
Geoforce
That article was released 24 June 2021 in the applied radiology journal and Mike’s comment were from June 2021 as well so I wouldn’t read anything into this being a new press release. I think what may of happened is when you search the journal it comes up with today’s date not the date of when it was published. I believe this is an old press release not a new one
Thanks
The comment from Mike was from June 2021
https://www.imagingbiometrics.com/wpib/wp-content/uploads/2022/03/2021-06-IB-Awarded-Patent-IB-Zero-G.pdf
Thanks
Yet more info on the voucher process
This seems to be an update from last week. So we need to get the drug status by September 24 then claim the voucher by September 26, still not sure if we need to get drug approval to get the voucher but seen as we are now being fast tracked it gives us a final deadline of sept 26 to get the drug approved by. That seems very quick to get phase 2 and 3 completed.
“RPD Designation Program Sunset Provisions
On December 27, 2020, the Rare Pediatric Disease Priority Review Voucher Program was extended. Under the current statutory sunset provisions, after September 30, 2024, FDA may only award a voucher for an approved rare pediatric disease product application if the sponsor has rare pediatric disease designation for the drug, and that designation was granted by September 30, 2024. After September 30, 2026, FDA may not award any rare pediatric disease priority review vouchers.
For any questions, please contact the Office of Orphan Products Development at orphan@fda.hhs.gov.”
Let’s see what update we get from Mike if we get PRD designation next month.
Have a great new year everybody
Thanks
This is an informative article about when you can apply for the PR voucher by a company that has been designated as a rare paediatric drug. The part just under the highlighted section seems to imply it will be many years before we can get a PRV ie after we have applied for it to accepted as a new drug.
https://laminarpharma.com/laminar-pharma-receives-rare-pediatric-disease-designation-from-the-u-s-fda-for-lam561/#:~:text=RPD%20Designation%20is%20granted%20by,than%2018%20years%20of%20age.
However, this contradicts the all process (rare paediatric drug designation) is due to be stopped (next year) I believe
The more you dig the more confusing this situation becomes.
Let’s hope Mike is fully conversant with it.
Thanks