Friday, February 12, 2021 9:37:40 AM
All Phases of a drugs' clinical trial data become part of the BLA application (shh, don't tell GD that BLA application was mentioned)
I'm not covering ground posters don's already know.
The trial holds 928 people - and how many more that were found upon biopsy to not have HNSCC. (Happened in a group of just 20+ people in Phase 2)(Think evaluable)
The data from this trial will have considerable impact.
Data should be formatted the same: Trial had three different CRO's and did TEVA run their own?
Geert is expecting to use this data to not only submit a BLA but to make Multikine part of the Standard of Care.
Don't believe one has the ability to go back and change the data from the study once it's finalized.
Get it right - only has one opportunity at this.
Take all the time you need - not going to throw away 30 years of effort over a few weeks rush to put out data.
Edit: The idea that the longer it takes the worse the data is - such bullhokey.
928 participants - three arms - years and years of data.
Just one piece of the data to assimilate: every investigators analysis of every patient. Holy dataload!
100 countries - how many languages? And the sentence structure is not synchronized in all languages. (Listen to Geert for example) Put all those reports in an unified, single format.
Personally was fortunate for the recent SP spike was able to sell the few Feb calls for a nice pile of coin.
Have recently moved all the Apr calls and started picking up Jul.
Nothing to do with the up to the minute timing of data release, just thought - move it further out and stop watching this so often.
Recent CVM News
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