Replies to post #182969 on Cytodyn Inc (CYDY)

[StealthGold]

The Philippines EUA in a few weeks is not going to happen. Don’t set yourself up for disappointment. NP deliberately left that to be inferred by how he said what he said but the reality is not that at all.

[mjbaker84]

You don’t understand Misiu. There is no money left to get through this year without one of the following. A/s increase (still can’t sell as s-3’s are effective), r/s, bankruptcy. This is all because of Nader.

[Bill_ENG]

You are correct .

It is much better to take an extra three months or even more to ensure the BLA is submitted correctly.

Seems like NPs newest addition either spotted some weakness or at the least, advised Cytodyn on being more precise and bringing in someone to vet the clinical portion before submission.

When you get one chance to hit the bullseye every 1 1/2 years you have to make the shot count.

Getting someone who has actual experience submitting each module is the best chance of approval. Those modules will each require different experts.

The FDA BLA rejection rate has gone over 50% since the Alzheimer's debacle, it used to be below 20% . Another point, it actually might be better to wait till FDA leadership is solidified before submitting.

Having good or better than good results in Brazil would change the perception of Cytodyn as a " easy to kill upstart".

Jmo

[ClosetInvestor]

“Yes , look that BLA is a very difficult
thing to finish , at this point I don’t care if is done one month later or sooner , but I just want to be done well ..”

Misiu….how can you, with a serious face, agree to give more time to NP for the BLA? The combo trial finished, successfully, in 2018 and we were told it would be submitted in early 2019. At this point, in 2021 and given NP’s comments yesterday. any reasonable investor would start asking serious questions on why it’s delayed delayed further, especially when we were told Recknor would get it filed by October 15th.