Cytodyn Inc (CYDY)

[finesand]

bringing back short term catalysts ODD + FTD, thanks to sjacobs,
which may allow a little pump mid-end of May?

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147488420

They also could use the TNBC injection if it will happen
before selling some stock - we will see how wise they are able to play these.

However, if any or both ODD + FTD got rejected,
$CYDY won't say a word. Example: If it is past 11th May, FTD could have been rejected, etc etc.

Quote:
20 Feb PR:

“BASED ON STRONG RESULTS IN ITS PRE-CLINICAL ANIMAL STUDY, CYTODYN FILES FOR ORPHAN DRUG DESIGNATION FOR TRIPLE-NEGATIVE BREAST CANCER”

https://www.cytodyn.com/media/press-releases/detail/317/leronlimab-pro-140-reduces-by-more-than-98-human-breast

...

ODD within 90 days: “The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and respond to all new applications within 90 days of receipt during his testimony before a Senate subcommittee.”

https://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/howtoapplyfororphanproductdesignation/default.htm

(End of May 2019 for us - roughly)

+++

March 11th

“The metastatic tumor volume was reduced by more than 98% after 7 weeks. On that basis, CytoDyn has recently filed an application with the U.S. Food and Drug Administration (FDA) for Fast Track Designation for leronlimab (PRO 140) in mTNBC.”

https://www.cytodyn.com/media/press-releases/detail/320/cytodyn-reports-significant-reduction-in-breast-cancer

...

FTD within 60 days: “FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.”

https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm

(May 11th 2019 for us - roughly)