Hi all,
In the webinar amongst some of the slides I found an interesting comment.
" Completion and results from the fully funded Phase 1/2 MND trial . Interim results may provide PK ( pharmacokinetic) and PD ( pharmacodynamics) data.
The emphasis is on the word may.
Everyone here agrees that to achieve Orphan Drug Designation from the FDA and or the TGA we need to present PK and PD.
Also of interest is that the PAA announcement 02/12/22 states " the progressive elevation of MPL levels , as we progress PK evaluation in MND will facilitate the determination of safe dosing levels for our Covid trial.
Notice the word will.
Same announcement states " Safety and efficacy data from the MND trial will facilitate a Phase 2 study in Covid 19".
So can anyone objectively explain what has happened.
Cheers
Kpax
Hi all,In the webinar amongst some of the slides I found an...
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