Replies to post #55194 on Ayala Pharmaceuticals Inc (ADXS)

[ubmmg]

Zach,
Good analysis, thank you.
I just wanted to pointed out the timelines for approval from that report (Page 10):

Authorisation process
Just under half (14/30) of applications that
eventually resulted in granting of a conditional
marketing authorisation contained a proposal
for this authorisation type in the initial
submission from the applicant. In other cases
the proposal for a conditional authorisation
was made either during the initial assessment
(14/30) or at the re-examination stage (2/30).
This likely indicates a certain reluctance of
applicants to proactively propose a conditional
authorisation type already in the initial
application.

Unsurprisingly, later consideration of
conditional marketing authorisation was linked
with longer total duration of the assessment
procedure (including clock-stops). Average
(mean) combined duration of assessment
and clock-stops is presented in the figure
below, while median duration showed similar
differences (323, 407 and 483.5 days for
initial application, assessment procedure and
re-examination, respectively). The average
assessment and clock-stop duration for all
positive opinions in centralised procedure
in 2015 was 202 and 131 days, respectively7.
It has to be noted that only three conditional
marketing authorisations were granted
following accelerated assessment (Darzalex,
Isentress, Tagrisso), and the combination
of these two early access tools has been
now encouraged in a revised CHMP guideline.

Thus, we will need to patient to see a conditional approval. There were exceptions, however. February/March 2019?

[ignatiusrielly35]

Yes, it was Chemist. What is your view, if there is approval, on the issue of market acceptance by the EU medical community, due to the limitations of the data that ADXS is using? Given the safety factor and the “last resort” nature of the treatment. And are results for other indications material to the question?

[Donjayouworry]

Thanks Zach. Really well done.