Replies to post #170195 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

ANAVEX2-73-PDD-001

D.3.8 to D.3.10 IMP Identification Details (Active Substances) 
 D.3.8	INN - Proposed INN	ANAVEX2-73 
 D.3.9.2	Current sponsor code	ANAVEX2-73 
 D.3.10	Strength 
 D.3.10.1	Concentration unit	mg milligram(s) 
 D.3.10.2	Concentration type	equal 
 D.3.10.3	Concentration number	10 
 D.3.11 The IMP contains an: 
 D.3.11.1	Active substance of chemical origin	Yes 
 D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No 
 The IMP is a: 
 D.3.11.3	Advanced Therapy IMP (ATIMP)	No 
 D.3.11.3.1	Somatic cell therapy medicinal product	No 
 D.3.11.3.2	Gene therapy medical product	No 
 D.3.11.3.3	Tissue Engineered Product	No 
 D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No 
 D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No 
 D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No 
 D.3.11.5	Radiopharmaceutical medicinal product	No 
 D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No 
 D.3.11.7	Plasma derived medicinal product	No 
 D.3.11.8	Extractive medicinal product	No 
 D.3.11.9	Recombinant medicinal product	No 
 D.3.11.10	Medicinal product containing genetically modified organisms	No 
 D.3.11.11	Herbal medicinal product	No 
 D.3.11.12	Homeopathic medicinal product	No 
 D.3.11.13	Another type of medicinal product	No 
 D.IMP: 2 
 D.1.2 and D.1.3	IMP Role	Test 
 D.2	Status of the IMP to be used in the clinical trial 
 D.2.1	IMP to be used in the trial has a marketing authorisation	No 
 D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No 
 D.2.5.1	Orphan drug designation number	 
 D.3 Description of the IMP 
 D.3.1	Product name	ANAVEX2-73 
 D.3.4	Pharmaceutical form	Capsule 
 D.3.4.1	Specific paediatric formulation	No 
 D.3.7	Routes of administration for this IMP	Oral use 
 D.3.8 to D.3.10 IMP Identification Details (Active Substances) 
 D.3.8	INN - Proposed INN	ANAVEX2-73 
 D.3.9.2	Current sponsor code	ANAVEX2-73 
 D.3.10	Strength 
 D.3.10.1	Concentration unit	mg milligram(s) 
 D.3.10.2	Concentration type	equal 
 D.3.10.3	Concentration number	20