CYDY's FDA string-along scenario

١٢ سبتمبر ٢٠٢٠

So far we haven't seen any indication that FDA or other agencies are in a hurry to approve Cytodyn's Emergency Use Authorization request or otherwise accelerate their trial and manufacturing process, despite Cytodyn's strong Phase II blind trial results and leadership in the race amongst pharmas to convincingly prove out a strongly safe and effective COVID treatment. Suppose this situation continues with Cytodyn publishing good Phase III interim results in October yielding retest of $10 in B, yet FDA continues to stall requesting more data or Phase III final results, and November's elections results flounder in turmoil. It would be sad but conceivable that FDA approval is delayed all the way to December or January, causing extended oscillation in $3-$10 range as shown here. Then the duration of wave II correction since July $10 high might rival duration of wave I run up from mid-December 2019 until July 2020.

This week ended with a drop back into 3s in what looks like a minor wave iv correction with a wave v into mid-5s expected next week or so, to be followed by another correction toward $4.

For the good of the country, we all hope for quicker action by the government to prove out the promise of leronlimab with lives saved this fall and a quicker path to double digits, but it's not clear whether rational actors are still at the helm.