"Keep your head straight when all about you are losing theirs." So far, the Anavex 2-73 clinical trial has met its goals, and safety has been established. This is highly meaningful, because safety is first and foremost a primary concern of the FDA.
Efficacy is to be proved or disproved in the ongoing clinical trial although the science behind the development of Anavex drug therapy is encouraging. Efficacy is certainly not an appropriate topic by me, a political scientist (Adam F) or short sellers (Martin S) or anyone else. It is important, however, that the Anavex 2-73 clinical trial has given indications that have been described as "encouraging" by scientists and medical practitioners. Any further comments or conclusions about these indications should be ignored, because these comments and conclusions are truly meaningless.
Briefly, I have tried to look generally at stages of FDA clinical trials, and how the Anavex study or trial is proceeding (SOME OF MY NOTES OR COMMENTS ARE IN ALL CAPS WITH PARENTHES):
Phase I:
The first investigation of a potential new drug in people, to determine how the drug reacts in the body, and how the body reacts to the drug – how it is absorbed, distributed and metabolized or altered / used by the body. Commonly conducted in a small number of healthy volunteers. (ANAVEX 2-73 PHASE HAS SUCCESSFULLY COMPLETED PHASE ONE.)
Phase II:
The first study to focus on the clinical effectiveness of the drug, and therefore performed in patients with the disease. At this stage the studies also determine any short-term side effects and safety risks associated with the investigational drug. (ANAVEX 2-73 HAS DEMONSTRATED SAFETY. THUS FAR, THERE ARE NO SIGNIFICANT SIDE EFFECTS. SOME DIZZINESS HAS OCCURRED WITH SOME PATIENTS, BUT DIZZINESS MAY BE A SIDE EFFECT OF ALL CNS DRUGS. REMEMBER: EVERY DRUGS APPROVED BY THE FDA HAS SOME SIDE EFFECTS! ALL PRESCRIPTION DRUGS HAVE POWERFUL ACTIVE INGRIEDIENTS. THESE INGRIEDIENTS MUST BE POWERFUL IN ORDER TO WORK!)
Phase III:
Studies carried out in large numbers of patients, comparing the investigational drug with the best existing treatment or standard of care in that particular disease. If positive results are obtained all data to date is compiled into a dossier and an application is made to REGULATORY authorities to request a license for clinical use. (THIS IS WHERE EFFICACY WILL BE PROVED OR DISPROVED. IF ANAVEX 2-73 SHOWS ANY EFFICACY AT ALL, IT IS LIKELY TO BE APPROVED BY THE FDA AS DONEPEZIL WAS APPROVED.)
NOTE: One of the several side effects of Donepezil is dizziness! It is dishonest for Adam F, political scientist, to discredit Anavex 2-73 for this side effect.
Phase IV:
Also known as post-marketing studies, these are conducted after the drug is approved by regulatory authorities and may include thousands of patients. These trials are generally designed to evaluate the long-term safety and efficacy of a drug, and to test it in a “real world” setting of daily clinical practice.
(ANAVEX 2-73 MAY MOVE TO THIS PHASE IF IT OBTAINS EARLY APPROVAL SUCH AS BREAK THROUGH THERAPY APPROVAL AS ANAVEX HAS ANNOUNCED THAT IT INTENDS TO PURSUE)
Do your own DD. Decide for yourself. Anavex 2-73 may or may not succeed. Clinical trials are much more complicated than I have outlined above. However, I have gone through the above steps to keep my head straight as we are all confronted by those that attempt to freighten or panic the market for their personal benefit. If I have incorrectly stated anything, please let me know. Any useful comments will be appreciated.
