Friday, December 29, 2017 10:09:51 AM
For l.p. to hold back the trial at these percentages are unethical so why haven't the Germans stepped in.
Because the sentence before that reads:
"Diese Ergebnisse sind als explorativ zu betrachten."
This document, first shared by yours truly 3 years ago, is the German DCVax "Label".
It has all the elements of a drug "Label".
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION BY AGENTS AND OTHER INGREDIENTS
2.1 QUALITATIVE DESCRIPTION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 APPLICATIONS
4.2 RECOMMENDED DOSE , AND METHOD OF APPLICATION
4.3 CONTRAINDICATIONS
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
4.5 INTERACTIONS WITH OTHER MEDICINES AND OR OTHER MEANS
4.6 USE DURING PREGNANCY AND BREAST-FEEDING
4.7 EFFECTS ON EFFICIENCY AND USE MACHINES
4.8 EXPECTED SIDE EFFECTS / ADVERSE REACTIONS
4.9 OVERDOSE
5. PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
5.2 Pharmacokinetic Properties
5.3 NON- CLINICAL STUDIES
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 INCOMPATIBILITIES
6.3 INFORMATION STORAGE
6.4 SPECIAL STORAGE CONDITIONS
6.5 NATURE AND CONTENT OF CONTAINER
6.6 ADVICE ON HANDLING AND DISPOSAL
7. AUTHORISATION HOLDER UNDER 4b AMG
8. AUTHORIZATION NUMBER:
9. DATE OF APPROVAL
10. DATE OF INFORMATION
11. FOR SUPPLY
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