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  4. CytoDyn Inc (CYDY) Message Board

It was comments made on this seeking alpha article

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Post# of 155581
(Total Views: 300)
Posted On: 07/20/2019 8:30:53 AM
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Posted By: trding
Re: misiu143 #5075
It was comments made on this seeking alpha article, where they made a new blog and linked with comments. I'm guessing they posted on ihub also, so it was probably old news to everyone but me.

https://seekingalpha.com/news/3476111-new-sen...or-cytodyn

Quote:
I posted a status update on $CYDY 'Where are you?'
Update, including latest PIPELINE 2019 report on (CD03) Monotherapy.
Thanks to Sandra (Feinsand) who perceived the results and current status spot on. finesand.wordpress.com/...



Quote:
i-base.info/...
"Leronlimab has been in development for more than a decade,
but that has been designated fast-track status, for potential to
treat MDR HIV. In addition to use as an ARV in combinations
leronlimab is also being studied as a switch treatment after viral
suppression on oral ART. Some people have reported sustained
viral suppression for two years using weekly subcutaneous
injections.
Preliminary results from a phase 2 study using this strategy were
presented at CROI 2019. [28]
Unfortunately, this reported a high failure rate at the initial 350 mg
dose that was not overcome with higher doses. Approximately
65% (149/226) of participants in the 350 mg, 33% (38/115)
in the 525 mg arm and 14% (6/14) in the 700 mg arm, had
confirmed viral rebound >200 copies/mL. Failure rates might
increase further as some participants are still ongoing. Some of
these participants are counted more than once as people with
viral failure were given the option to return to ART or roll over to
a higher dose of leronlimab." etc ..

And it matches the CROI2019 poster, referenced and elaborated in my post above.



Quote:
Sorry bigjuicy, but the only canonical source of results is CROI2019 here.
BTW, if I take off the lead-in period with their failures, the respondent percentage does match these stock promotional (but not scientific) claims.

CYDY had two monotherapy trials and both didn't make the endpoint = failure.
It doesn't really count that CYDY is extending and extending the CD03 trial .. it is done and a the new trial IND also not being accepted by the FDA yet.

It gets better now: NP's communicated that the Aug/Sep BLA filing completion might be contingent upon the FDA to accept 525mg where they just requested 700mg?

It is a rough place for them.

Up until August 14th they have to file the 10-K.



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