Cytodyn Inc (CYDY)

[pearsby09]

Negatives:

5 Rebounders
Small "N" so far on all accounts
Low volume and PPS Post CROI...seemingly No Interest or BO hype..not good!!
Overall Market at Record highs
Competition moving forward
No Cash to deter Dilution..which will be very soon!
Dosing escalation to address Rebounders/Break Through/Resistant patients..what ever Term makes you happy!
Dosing Escalation to address rebound..not always a sure thing..plus potential newly surfacing AE's with higher dosing and another dosing trial at the P3 level for confirmation.
Many times a Higher dose regimen constitutes a separate trial..Not a dove tail off an existing trial...Efficacy/AE profiling titration trial
Only effective in CCR5 Patients..loss of overall Market opportunities

Positives:

FDA seems to be on CYDY side...150 to 30 "N"
Fast Tract Designation, Cure Act legislation, AA mandate for unmet disease states
Once/Twice weekly SC for compliance
Low AE's at this Juncture
GILD in need of replacing Oral Haart Therapy via patent expiration's
Potent VL suppression in many patients for over two years
Historically, NIH support...20 plus million!
Quality of Life testimonials by several PRO 140 Long term patients
BTD filing....???
ODD Filing...???
BLA Filing....???
Multi Billion dollar Market potential Adjunct/Mono
Preemptive Manufacturing alignment..good vibes!
2 Plus years VL suppression..showing long term sustainability in regards to efficacy
Compatible with other therapies