Kingpin post: Timing & Content.15 Jun 2023 07:41
Whilst i remain suspicious of the authenticity particularly given the timing of release and inconsistencies in stockholding , for argument sakes, let’s take it all at face value and consider the content.
There is a positive within, that being a statement that Car-T will progress to clinic.
There’s also a negative.
The statement of, the Major concern is being addressed.
Why is that a negative?
By implication there must be more than the Major concern to attend to, ie more FDA identified deficiencies than the one.
It’s really important to understand this point!
The FDA review of Hemo’s response to the deficiencies letter will only start on a submission of a “Complete Response” to ALL the deficiencies raised.
For me the concern remains completely unchanged by the information in the post, that being ;
Time line to CH resolution, associated cash burn and advancement of competing treatments.
In summary, nothing new and still no timeline but don’t panic !
I’d add a note of caution.
The correspondence would legally be considered private and not within the public domain .
The company communication within the public domain,the RNS, makes no mention of confirmation Car-T will progress to clinic.
I wonder why the difference!
AIMO