Cytodyn Inc (CYDY)

[finesand]

saltz- FDA was always very supportive, but just not when they increased the safety requirements from 100 to 300, now back to mid point 150. But supportive in a way to allow all amendments in the trials, guess that is their job.

Yes, Monotherapy proving 70% of pts to get a reliable VLsup would be a dream come true. That is what is lacking with CD01 + Ext trial data. Somewhere in 2H19 we might have enough data to convince the FDA the latest, my hope.

Nader IMHO is sort of changed his views, but still giving too bullish expectations for Mono - Not Combo.
Now he talks about 4 years is quick compared to some 15 years of development - so that is OK. But if you would analyze his talking, you would realize he is indeed too impatient with .. investors?

So we shall have Combo BLA acceptance in June '19 the latest if CMC allows. And since they won't officially file it before 100% certain - that would be as good as approval.
And of course, while Combo is not the revenue home run yet, but significant for this little tiny company - it will then open up the doors to label expansion via sBLA applications.
That is the game play starting around June '19.

Since we are talking long term investment here, all is good.