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misiu143

05/12/19 12:32 AM

#40837 RE: Amatuer17 #40836

Amatuer - I was just going to bed when I looked here ..,

You are very smart , I know that , and some things are hard for me to believe !!!

-Ok , do you want to be right ???
and this medicine will not be available to very sick patients with different , very difficult diagnosis , for many years ??
And maybe some of this patients with time will be us ??
Is that what you aim for ???

-Do you want this medicine , helping saving many life’s to
be delayed ..

-Is that what will make you happy .,,

- don’t you think that shorts , or so
, should find other companies to play with , but not the one which may save many life’s including theirs one day !!

-I must say , I rather be to optimistic than not ,
at least I always think , help is around the corner !!! It will be hard for me to live other way !!


GN now ,,,





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ohm20

05/12/19 1:02 AM

#40838 RE: Amatuer17 #40836

With your previous timeline the primary completion would be April 2021, not Sept/Oct 2021.

"Here are my guesses (min)


Protocol submission/FDA feedback: about 5 weeks from now.

Initiating trial and full enrolment: 12 months

Trial completion - 48-weeks from last patient"




"Primary completion date that NP will mention in trial on clinical trials.gov site - based on no of patients to be enrolled = 300, the primary completion date will be Sept/Oct 2021."