manufacturing readiness? ppq and p3 enrollment REQUIRED...
listen, please, again,
i am expecting VERY good data, soon.
i am not deeply invested like all of you because my life untangled and i have no money. but i am still invested enough to be very hopeful of a share price reset. i believe that will happen, WITHOUT an approval and maybe even prior to any partnerships, should there ever be one.
now please... here we go with some further sobering facts. they are what they are. its not "bad" its just the way things are.
and again.. an approval is not necessary for this investment to be fantastic for all of us.
from my prior post:
cytodyn has a 2 year minimum timeline to approval which, theoretically, but not at all realistically, could have a few months shaved off by a rolling review or an RTOR review.
However there is more to the timeline, sadly, but its ok...
FOR ALL APPROVAL PATHWAYS and
FOR ALL REVIEW ACCELERATORS
two things are 100% required.
1) in january 2025 the fda made it MANDATORY for all accelerated approvals to FIRST have a PHASE 3 TRIAL ACTIVELY ENROLLING. where is the bold/underline feature? red flashing text? an alarm sound?
god almighty i despise using caps i am sorry but i don;t understand how else to get people to STOP and take note of things.
there are no exceptions. cytodyn, just to have an accelerated approval application BEGIN to be reviewed, would have to create a p3 protocol, get it approved, choose clinical sites, go thru that long process of site setup, have everything funded, screen trial applicants, and begin enrolling and dosing patients.
2) "manufacturing readiness".
that phrase in the 8k was absolutely meaningful. that's good news. for ANY BLA to be reviewed, the fda FIRST requires 6 months of stability data from your current manufacturer. cytodyn is going to begin that costly process. three commercial batches are required by the fda. and once they complete the batch runs, then you also need those batches to "sit" for 6 months in order to then prove "stability".
the good news is that the manufacturing ppq (process performance qualification) is about to be initiated.
the less than perfect news is the cost. probably something like $10m? could be much more. its millions per batch and they need three batches.
the other annoying piece is the time it will take. without factoring for manufacturing slot wait time, this process would take AT LEAST to end of the year to have 6 months stability. and the harsh reality is that the wait time for a manufacturing slot is probably minimum 6 months and potentially much longer.
that's wait time for a slot is everywhere, for everyone, even big pharma. slots are commonly scheduled and paid for a year or more in advance. there's only so much manufacturing capacity out there, hence the massive global expansion in the last 10 years which is still in full swing.
*****
so in the end you have a basic 2 year process starting from the completion of the trial or its early termination. so first you need that early termination. plus 1 year data processing resulting in a BLA. and then roughly 1 year of the fda reviewing the BLA...
BUT ALSO whatever time and money it takes to get to 6 months stability testing AND ALSO the time and money it takes to push through and fund the start of a p3 confirmatory trial.
the filing fee for a BLA is 4.7m btw.
listen, please, again,
i am expecting VERY good data, soon.
i am not deeply invested like all of you because my life untangled and i have no money. but i am still invested enough to be very hopeful of a share price reset. i believe that will happen, WITHOUT an approval and maybe even prior to any partnerships, should there ever be one.
now please... here we go with some further sobering facts. they are what they are. its not "bad" its just the way things are.
and again.. an approval is not necessary for this investment to be fantastic for all of us.
from my prior post:
cytodyn has a 2 year minimum timeline to approval which, theoretically, but not at all realistically, could have a few months shaved off by a rolling review or an RTOR review.
However there is more to the timeline, sadly, but its ok...
FOR ALL APPROVAL PATHWAYS and
FOR ALL REVIEW ACCELERATORS
two things are 100% required.
1) in january 2025 the fda made it MANDATORY for all accelerated approvals to FIRST have a PHASE 3 TRIAL ACTIVELY ENROLLING. where is the bold/underline feature? red flashing text? an alarm sound?
god almighty i despise using caps i am sorry but i don;t understand how else to get people to STOP and take note of things.
there are no exceptions. cytodyn, just to have an accelerated approval application BEGIN to be reviewed, would have to create a p3 protocol, get it approved, choose clinical sites, go thru that long process of site setup, have everything funded, screen trial applicants, and begin enrolling and dosing patients.
2) "manufacturing readiness".
that phrase in the 8k was absolutely meaningful. that's good news. for ANY BLA to be reviewed, the fda FIRST requires 6 months of stability data from your current manufacturer. cytodyn is going to begin that costly process. three commercial batches are required by the fda. and once they complete the batch runs, then you also need those batches to "sit" for 6 months in order to then prove "stability".
the good news is that the manufacturing ppq (process performance qualification) is about to be initiated.
the less than perfect news is the cost. probably something like $10m? could be much more. its millions per batch and they need three batches.
the other annoying piece is the time it will take. without factoring for manufacturing slot wait time, this process would take AT LEAST to end of the year to have 6 months stability. and the harsh reality is that the wait time for a manufacturing slot is probably minimum 6 months and potentially much longer.
that's wait time for a slot is everywhere, for everyone, even big pharma. slots are commonly scheduled and paid for a year or more in advance. there's only so much manufacturing capacity out there, hence the massive global expansion in the last 10 years which is still in full swing.
*****
so in the end you have a basic 2 year process starting from the completion of the trial or its early termination. so first you need that early termination. plus 1 year data processing resulting in a BLA. and then roughly 1 year of the fda reviewing the BLA...
BUT ALSO whatever time and money it takes to get to 6 months stability testing AND ALSO the time and money it takes to push through and fund the start of a p3 confirmatory trial.
the filing fee for a BLA is 4.7m btw.
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