Replies to post #34720 on Cytodyn Inc (CYDY)

[IPO$]

what is probability in your opinion of acceptance versus rejection from FDA?

[finesand]

Required Safety Data ..

It moved 100pts -> 300pts -> 150pts and now 100pts again.

2017-07-18 CC 150pt required for SAFETY ANALYSIS in BLA: provided by all HIV trials of pts on PRO 140 for 24 weeks [w/ >= 350mg weekly SC 2017-11-30 10-Q]
– FDA amendment from 100pt and 300pt (2017-10-13)

see https://finesand.wordpress.com/2018/07/21/comparison-hiv-1-anti-infective-antibodies/

Around mid 2018 they should have completed it w/ 350mg, and CD03 was completed until they added the higher dosage up to 700mg on 2018-07-17.

Now FDA agreed to align new high dosage and safety, while reducing the number of pts "which enables the BLA submission for the combination therapy to use 700 mg instead of the original 350 mg dose".
So that is an excellent reasoning and FDA wants them to use the 700mg even in Combo for higher efficacy, besides using same safety data for Mono + TNBC.
(Double the dosage may also justifies the higher WAC a little more)

74 pts (45 + 29) are already in mono w/ 700mg and more added (see PR), so enrollment is no issue.
Some other pts in extension trial were also going to 700mg AFAIK.
They can use any 700mg pts of any trial arm, at least this was the last communication with 350mg dosage.
Should be no issue to complete 1H19, the latest if they haven't already.

CD02 Combo Study is completed, so is the original CD03 Mono.

CD03 Mono gets presented this March at CROI

gestalt:

I was also not aware that this 700mg safety acceptance was even part of the discussion with the fda. I thought the safety arm was done. It is good news and will pay off in future indications for sure but it is not the mono trial protocol approved type pr.

[Amatuer17]

In the presentation, Nader clearly mentioned that Mono needs a new pivotal study and protocol approval in H1-2019 - with 24 or 48 weeks trial, mono will not complete in 2020 for sure. It will go into 2020.

So company spending money on
1. BLA preparation and submission - including CMC Steps

2. TNBC trial at multiple location and then go with next phase

3. Continue with mono 700 mg safety

4. Submission of protocol for pivotal P3 for mono and payment to CRO to start trial

5. Restart gVHD trial

6. 510K for prostate cancer testing

This is too much activity in next 6-9 months. Unless they come with non- dilutive finance source, we can see massive dilution or many of the activities above will just get delayed to 2020.
In this scenario we will be in 40-50 cent range for long