Adam Davidson, CEO of Trident Royalties, discusses offtake milestones and catalysts to boost FY24. Watch the video here.
Mr I,
I’m not in a battle and sorry you feel that’s what it is.
I will though correct those who misinterpret the facts, either deliberately knowing or through ignorance.
True, i was expecting some news for a push to Tranche 1 SP , and that hasn’t happened…yet !
AIMO
HH,
Please stop with the fiction !
The company have NOT submitted a complete response as you claim.
The company have advised within the RNS that the FDA are satisfied with their “Plan” to resolve.
The plan now has to be executed inclusive further testing.*
Upon completion the company will THEN submit their complete response and FDA then review for adherence to the plan prior to clearing with lift of CH.
No more stories today please, don’t have time to correct!
* Preliminary testing as mentioned within RNS , determines final testing for approval to follow.
AIMO
Digitt,
So your answer to why no timeline is;
it’s not within the company’s control as third party testing required and the FDA will use up unknown time to respond!
1. Testing is required or else there would be no ref to “preliminary testing “ within the RNS. The company know how long it’s taken previously, so it is not the unknown you suggest it to be.
2. The FDA are not required to comment again until resubmission, so no time element there !
You’ve not answered the simple question I posed.
AIMO
No more response today as other stuff to do.
Bline,
I have ! ..I thought a bigger bump in SP.
Seems the market has understood what many here have not.
It’s a step forward on a path that’s now clearly defined.
How long the path and the cost to reach the end, unknown.
Thumbs up to the company for at least communicating progress.
AIMO
HH,
That’s the most blatant and inaccurate post I’ve ever seen of yours!
I will only state the FACTS within the RNS.
The company has a plan that’s now been accepted by the FDA. Should that plan be executed as proposed, then CH should be lifted.
There’s no timeline on when and there’s no guarantee the plan will be executed to FDA satisfaction.
Therefore to state CH is effectively lifted is utter rubbish!
AIMO
Micky,
The good news, i think a good bump to SP today and if so I’ll be happy for the LTH’s.
The bad news , clearly it’s not the lift of CH many had predicted.
The fix required is significant where many had claimed it trivial.
There’s no timeline on resubmission and by way of note on “preliminary testing”, there’s more required.
In summary, the company has a plan to fix that the FDA accepts. Unfortunately that’s it !
SP bump and placing to fund the works.
I hope for LTH’s i’m wrong.
AIMO
Should get a good rise on this as most won’t read it properly and comprehend the actual progress.
The RNS I predicted, the date I predicted and hopefully…goodbye.
No timeline to resubmission and further testing required.
Good luck all
AIMO
HH,
I’m sorry I strongly disagree.
The “single” issue you try to trivialise, some believe a fundamental problem that could involve very significant work, time & money to resolve.
The point being, it’s the seriousness of the issue and not the number !
AIMO
HH,
You sure that’s not 95% !!!!!
1. You don’t know what % has been accepted, so you’re statements false.
2. It’s not addressed until FDA considers it so, again a false statement.
JFH,
Dolphins can hold their breath for longer 😉
AIMO
HH,
Facts, Facts …Facts !
Nothing wrong in ignoring them if you wish, and nothing wrong in highlighting them either .
What is wrong is trying to convince others any reported fact that doesn’t fit your agenda is FUD .
I’m looking forward to more from HW as it seems, finally we have a properly qualified poster with valuable insight.
AIMO
HW,
Just catching up on posts and see your note to Pumpky.
I’m sorry but it did fail and Pumpky was correct .
It failed in its present form to CLEAR with the FDA.
We know it’s under CH until changes are made and supporting information provided that the FDA subsequently determines acceptable and as such, the IND application has not yet failed in its entirety and may not.
AIMO
HW,
Given your background i’m sure your aware many are expecting the FDA to give the green light on a CRISPR gene edit treatment for SCD blood disorder in December this year !?
I wouldn’t disagree, CRISPR editing is more complex , newer and more scientifically advanced and as such , getting through the approval processes more involved.
Just think your timelines out… considerably!
Separate to the above(Vertex/Crispr), a more relevant CRISPR gene edit IND for AML treatment due this year (Caribu) !
Not sure how your comment below fits with the above ?
“Long answer is that this will take years/ decades to come into clinical use as it is essentially gene editing”
AIMO
Digittt,
“So I'll take the DOD's view so far that this is a potential microsoft of viral treatments over yours, thanks.”
Anytime you’d like to corroborate your words above would be great for all to witness.
It’s ok to get a little riled and immature when you’re questioned and don’t have an answer . We all make the same mistake on occasion, so no offence taken.
Good luck.
AIMO
Digitt,
Just for interest of the board , would you mind posting the DOD’s written confirmation that CBR’s the potential Microsoft of viral treatments, as you’ve claimed ? …only I can’t find it or any other third party independent reference concluding the same !!!
AIMO
Digitt,
I’ve already responded to the anticipated “not mature enough”argument,see previous post.
It may or may not ultimately have some application .
My point being, it is NOT the potential “Microsoft of viral treatments“ demonstrated by the route to fund development and considering the company cash position.
I believe a balanced and reasonable conclusion.
AIMO
Hulver,
As you say , it depends on your standpoint on CBR.
Those who’ve been promoting as the future “Microsoft of viral treatments”, should now understand how unlikely that is and always was.
Why ?
To have to hustle for potential funding, (whilst commendable from VS), demonstrates without any ambiguity that big pharma aren’t knocking at the door .
The reasonable conclusion, …CBR’s not the miracle breakthrough some have described it to be.
For those who never believed,… solid confirmation .
In anticipation of response .
CBR info is in the public domain for all to see including big pharma and no, it’s very unlikely VS is turning away multiple offers and preferring to fly solo when you consider the company’s cash position. Yes big Pharma would be interested even at this very early stage were it potentially the miracle breakthrough as others have claimed.
AIMO