cytodyn is and has been in a chicken egg problem. do they release a positive PR and try and get a higher SP then raise funds or do they raise funds to pay for the trial or whatever that leads to a PR that will raise the SP?
Years ago, when cytodyn was raising funds with paulson i use to get so angry because the would release a positive PR and the same day put out an 8k with some new funding raised which completely erased the positive impact of the first PR. the response from cytodyn was that the fund raising schedule and the positive PR schedule are completely separate and there is no way they can coordinate one relative to the other. I did not agree with that then and still don't. the only thing i have learned on top of that is that positive PRs by themselves rarely actually raise the SP to make a funding raise better afterwards. We would think it would but for cytodyn it does not work that way.
My guess is that the final step in submitting the BLA is the next PR, i hope. It could be they do submit the BLA, don't PR it until they get the PUFTA date from the FDA confirming that everything is ready for the FDA to do their final review. this avoids the expectation that filing a BLA means the FDA is good, when as we know they might not be and we need to fix things and re-submit. This is why i feel the end of quarter BLA deadline might be met, but we will not know for awhile.
I don't think resubmitting for the BTD for mTNBC will be PR'd until the FDA decides to give the BTD, if at all. The Nash data i think has to be PR'd as it is a material event, but they can just not finish the data analysis completely and hold on to this as they coordinate with the FDA for next steps.
I have no idea what is going on with Brazil, they are running things and if the primary endpoint is met, we would get a PR. we will not know how far along the enrollment is or anything else.
My next guess is that fund raising will be some sort of passing the hat around to big share holders and BOD member to keep things going. I don't think there are any streeterville funding plans anymore. as much as Samsung needs payment, that is to continue the inventory ramp up schedule, they can just pause that. FDA approval is the focus in my opinion. The silence is to give the FDA no reason to not just look and approve what is put in front of them.
Years ago, when cytodyn was raising funds with paulson i use to get so angry because the would release a positive PR and the same day put out an 8k with some new funding raised which completely erased the positive impact of the first PR. the response from cytodyn was that the fund raising schedule and the positive PR schedule are completely separate and there is no way they can coordinate one relative to the other. I did not agree with that then and still don't. the only thing i have learned on top of that is that positive PRs by themselves rarely actually raise the SP to make a funding raise better afterwards. We would think it would but for cytodyn it does not work that way.
My guess is that the final step in submitting the BLA is the next PR, i hope. It could be they do submit the BLA, don't PR it until they get the PUFTA date from the FDA confirming that everything is ready for the FDA to do their final review. this avoids the expectation that filing a BLA means the FDA is good, when as we know they might not be and we need to fix things and re-submit. This is why i feel the end of quarter BLA deadline might be met, but we will not know for awhile.
I don't think resubmitting for the BTD for mTNBC will be PR'd until the FDA decides to give the BTD, if at all. The Nash data i think has to be PR'd as it is a material event, but they can just not finish the data analysis completely and hold on to this as they coordinate with the FDA for next steps.
I have no idea what is going on with Brazil, they are running things and if the primary endpoint is met, we would get a PR. we will not know how far along the enrollment is or anything else.
My next guess is that fund raising will be some sort of passing the hat around to big share holders and BOD member to keep things going. I don't think there are any streeterville funding plans anymore. as much as Samsung needs payment, that is to continue the inventory ramp up schedule, they can just pause that. FDA approval is the focus in my opinion. The silence is to give the FDA no reason to not just look and approve what is put in front of them.
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