Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Has anyone had the dial in details for the AGM confirmed? Personally mine says awaiting registration approval.
I suspect he will continue as CFO as his name appears for reelection on the proxy form. I guess all will be revealed today.
Why if not by the AGM?
The AGM serves no purpose to the FDA. They will issue their letter within the set out time frame, they may have issued it already. We don’t know.
As I said next week the points stand, 30 days would have passed. Using the AGM is an attempt to justify your own personal timings is not cool.
Of course delays equal more cash burn, but for those interested in the long term (partnerships, trials etc etc) a week is not long at all.
Again, if no update next week your points stand.
Stu,
I would suggest you take up consulting and inform the FDA they have it all wrong.
The letter spells out both hold and non hold issues and the process guides you so confidently quoted stressed completeness. As a board there is huge upside risk in speaking before knowing the facts The market does not want piecemeal.
There appears to be an element of time pressure for you. Why this week? Why is waiting for the letter so concerning for you?
Stu,
Thanks for the back handed compliment.
Completeness …
Would it be right to issue a reach RNS stating what they are confident on the issue you kindly present as an example only to potentially be hit with further issues upon receipt of the letter.
Imagine the harm that may be caused if they followed your requests provide a statement in advance of knowing all the facts only to later receive a surprise.
As I said from next week onwards what you have said stands. Assuming the letter hasn’t arrived, as the 30 days haven’t passed, allow them to receive it look at it and then update us. No need to rush things, when we rush we make mistakes.
If the issues were that easy to solve Pumpky they would have been done over the phone. FDA will need to determine the completeness of our response and subsequently review it.
Whilst that would be the ideal scenario it is unfair to mislead.
Let’s hope for a simple “letter received, remain confident”
Really showing your trading agenda Stu, the best interest of shareholders would be to provide a meaningful update on the FDAs complete response at an appropriate time.
You are front running the fda’s stated timeline. Raise this points from Tuesday next week onwards and you will have some credibility
To say what exactly “we are still confident and still awaiting further detail?”
Your points would be valid if the 30days had passed. Don’t assume anything, the letter may have came the day after CH or it may come on the 30th day. We don’t know.
If you need your hand held by Reach RNS pharma isn’t for you. Try ETFs.
The deadline for the FDA letter hasnt passed… let’s stop changing the goal posts. Feel free to grumble next week. Very simple to count 30 days on the calendar …
Bline - that post really made me laugh.... :D
L200, youll feel better when the CAR-T partner is announced and hold lifted. Calling the exact bottom is pure luck. It could have easily gone the other way and your 2.5 could have been an enviable average.
For me the biggest short term catalyst would be announcing the partner with a deal in line with the below, should we receive a nice slice of cash as an upfront payment I don’t see is being anywhere near this price. GLA!
whilst i think we have all enjoyed the ride back to pre ind submission levels i thought it would be a good time to share some speculative views on the car-t partner and the potential deal we may get.
these deals are often three fold including upfront payments, milestone payments and royalties.
i’ve linked a couple of examples that i would be able to find and would be delighted to achieve something similar for our car-t product. that with a sprinkle of cbr should ensure all investors are looked after by the market.
- upon closing in january 2023, gilead’s kite made an upfront payment of $225.0 million and obtained a license to codevelop and co-commercialize cart-ddbcma for the treatment of multiple myeloma.
- under the terms of the agreement, janssen will pay cbmg an upfront fee of $245m, with the chinese biotech also eligible for certain milestone payments, as well as tiered royalties.
- ****nalbio bags $70 million upfront from roche car-t deal
- legend biotech entered into the agreement with janssen to develop, manufacture and commercialize cilta-cel for the treatment of multiple myeloma. under the agreement, legend biotech received an upfront payment of $350 million and is entitled to receive additional payments upon achievement of landmarks for development, production performance, regulatory and sales.
- kite will receive from amgen an upfront payment of $60 million, as well as funding for r&d costs through ind filing. kite will be eligible to receive up to $525 million in milestone payments per amgen program based on the successful completion of regulatory and commercialization milestones
- as previously announced, autolus and blackstone entered into a strategic collaboration and financing agreement in november 2021, whereby funds managed by blackstone agreed to provide up to $250 million in equity and product financing to support autolus' advancement of obe-cel, its cd19 car t cell investigational therapy product candidate, as well as next generation product candidates of obe-cel in b-cell malignancies.
keen to hear any views and also predictions!
gla
Unfortunately agree with Pumpky… they need to amend the misleading wording in those tweets
“We are here to discuss the CBR programme and some other programmes.”
Spends 27 minutes talking through everyone’s background… disappointing.
I hope we lose TMS soon, they are draining funds in exchange for tweets with rocket emojis…
Fingers crossed we get a meaningful IND update soon
Https://youtu.be/4u9NRLi67oE
Hope to all see you there !
JHFH is still in the share, he is busy with life outside of HEMO at the moment.
Glad to see Hemotruth has a calculator… to assume those who invest large amounts have perfect grammar and spelling is simply outdated and bigoted.
It seems the team made a recent hire from Cellectis ..
Welcome Jessica ! https://www.linkedin.com/in/jessicajang/
Their product line is interesting and I am certainly happy to see them on board. I do hope they dont read this BB though!
https://www.cellectis.com/en/products/product-candidates/