yes but rolling review doesn't just "happen". companies must request it and fda must agree to it. cytodyn typically informs shareholders of WAY more stuff than almost any other pharma company. while many shareholders feel the opposite, its simply true. most small biotech shareholders are left deeply in the dark about everything except data releases, conference dates and whatever shows up in a required filing.
while nothing is certain, i assume that if cytodyn hasn't mentioned rolling review, then they don;t have any such option currently. not that it can;t be added, but frankly, i don;t deal in anything that "hasn;t happened but theoretically could" and bread crumbs and such.
typically, rolling review comes with fast track and or breakthrough designation. it rarely ever comes unattached. cytodyn does not have those designations for mss-crc, as far as i am aware. and so i just don;t have rolling review on my radar for this indication at all.
beyond that, rolling review isn;t a big time saver overall. the clinical section is 90% of the work and volume. the clincial section comes after the trial is completed and after the data lock. regarding the non-clinical sections such as the CMC, their world class CRO won;t have any problem putting together a near bulletproof CMC, simultaneous to efforts on the massive clinical section. they don;t really need a rolling review. it might help, but its not that important.
if cytodyn were on their own or associated with a tiny outfit like amarex, then rolling review would be somewhat more important. it would then allow them to potentially get early IRs from the FDA on the CMC and potentially address concerns without adding to the overall timeline.
in the end, the vast bulk of the BLA work and review is initiated subsequent to the trial conclusion and the data lock months later.
the short-term goal, s partnership, not approval. in 2026, partnership could happen, approval can not. in 2027 a partnership could happen, approval can not. in 2028, its not very likely that an approval can happen, but it would have to be very late in the year imo. and for that 2028 approval to happen, every last thing would have to fall neatly into place - and as we all know, pharma works kind of the opposite, specifically regarding small biotechs.
i'd just like to see something get things moving with the share price, and watch the share price move to $1.30 and then see which way it goes from there and where it settles.
hoping that pd-1 expression is enough to fuel such a move, but its hard to say whether traders will understand the incredible value in that. biomarker data isn't usually considered to be all that exciting. maybe the tumor shrinkage will do the trick. there will be tumor shrinkage, obviously, and traders in that case won;t know that the shrinkage is actually going to be fleeting without the introduction of ICIs.
while nothing is certain, i assume that if cytodyn hasn't mentioned rolling review, then they don;t have any such option currently. not that it can;t be added, but frankly, i don;t deal in anything that "hasn;t happened but theoretically could" and bread crumbs and such.
typically, rolling review comes with fast track and or breakthrough designation. it rarely ever comes unattached. cytodyn does not have those designations for mss-crc, as far as i am aware. and so i just don;t have rolling review on my radar for this indication at all.
beyond that, rolling review isn;t a big time saver overall. the clinical section is 90% of the work and volume. the clincial section comes after the trial is completed and after the data lock. regarding the non-clinical sections such as the CMC, their world class CRO won;t have any problem putting together a near bulletproof CMC, simultaneous to efforts on the massive clinical section. they don;t really need a rolling review. it might help, but its not that important.
if cytodyn were on their own or associated with a tiny outfit like amarex, then rolling review would be somewhat more important. it would then allow them to potentially get early IRs from the FDA on the CMC and potentially address concerns without adding to the overall timeline.
in the end, the vast bulk of the BLA work and review is initiated subsequent to the trial conclusion and the data lock months later.
the short-term goal, s partnership, not approval. in 2026, partnership could happen, approval can not. in 2027 a partnership could happen, approval can not. in 2028, its not very likely that an approval can happen, but it would have to be very late in the year imo. and for that 2028 approval to happen, every last thing would have to fall neatly into place - and as we all know, pharma works kind of the opposite, specifically regarding small biotechs.
i'd just like to see something get things moving with the share price, and watch the share price move to $1.30 and then see which way it goes from there and where it settles.
hoping that pd-1 expression is enough to fuel such a move, but its hard to say whether traders will understand the incredible value in that. biomarker data isn't usually considered to be all that exciting. maybe the tumor shrinkage will do the trick. there will be tumor shrinkage, obviously, and traders in that case won;t know that the shrinkage is actually going to be fleeting without the introduction of ICIs.
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