Cytodyn Inc (CYDY)

[misiu143]

Stockorus and B52T38.. ( I no longer have PM )

BLA should not be affected by capcid inhibitor approval , except if FDA will still be trying to delay us intentionally ..
ROT is done already and filed to FDA June 30 to evaluate .
"The Dose Justification ", hopefully FDA will not have a problem with it this time.

As for capcid inhibitor , Lenacapavir , look it might be a good drug for HIV patients , and here they using for MDR ( multi drug resistant )
As LL combo patients.

Efficacy was about 73% at 26 weeks.
LL 81 % with 350 mg at 25 weeks.

SC injection every 6 months , patients will like that.

As much as 85% of patients developed some side effects , but mostly not severe , no patient dropped from a study.

Most common , irritation around injection site , sometimes nodules in this area staying for few months , some headache , diarrhea , nausea , fever , urinary tract infection ..
About 21% of patients showed severe laboratory abnormality including related to kidney function and blood sugar changes , but there were temporary..
So longer observation is needed , and more patients to observe.
Here they had total of 72 patients.
Personally I dont like that long acting drugs , since if severe side effect will appear , it will also be long acting.

There was no resistance developed in human , but they could produce resistance in a lab , which mean it will be a possibility..

They also doing study in PeEP , in preclinical study they used 2 different doses , with smaller 86% and with higher 96% efficacy.
Clinical study plan for later this year.

When we evaluate other problems we see in HIV patients , like ..
--Severe inflammation, which is base of most human diseases ,
--HIV dementia ,
--liver problems in 60-70% of this patients,
--increase number of different malignancies ..

Leronlimab will be a much better drug , since we think it will help all of these problems in addition to HIV.
NASH and cancers studies ongoing.

But doctors and patients will need to be well educated to see these benefits..

Closetinvestor - what your comments had to do with my post..

Professer , thank you.

all IMO , and this is my one post for a day...


https://www.gilead.com/news-and-press/press-room/press-releases/2021/6/gilead-submits-new-drug-application-to-us-food-and-drug-administration-for-lenacapavir-an-investigational-longacting-capsid-inhibitor-for-the-tre