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OFP

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Alias Born 12/13/2011

OFP

Re: anders2211 post# 134174

Wednesday, 12/13/2017 1:34:18 PM

Wednesday, December 13, 2017 1:34:18 PM

Post# of 458440

what you are saying is that Missling was lying through his teeth when he told us in the CC the Rett trial will start Q1 as is the PK

With everything he says you should look for the wiggle room and expect it's said with the intent to prop up the flagging pps. Did he mean start as in first dosing (I doubt it)? Probably when he gets a protocol in clinicaltrials or even FDA go ahead on the IND he'll claim he met that goal. So will it be lying if they don't start dosing in Q1?...not officially. Instead it will be phrasing or "unseen events".

No... the Rett syndrome trial takes 3 months


...for each patient. It will take all year to enroll the last patient and AFTER that it will be 3 more months.

after it starts the readout 1 month.

That would be remarkable for an efficient company. Three months I think of as standard. For AVXL, as a neophyte crew, I'd say 3 months is a minimum...esp. if they don't like their results in which case they have a history of data mining for a year before releasing results.

The FDA approval is, after that, just a formality, since it is an orphan drug so the SP can go already to the market cap as if it were approved...

Oh boy, nothing is a formality. The results of this study are far from certain. The Orphan Drug Designation ONLY means that they filled out the ODD paperwork for an indication with a small target population...it has essentially NO implications as to expectations to success.
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