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P2a is for safety not efficacy. Safety within the trial parameters (not LT use) gives the green light to go to 2b. It's a long jouney, and NTRP has just begun.
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I can't help but think you must be mixing and matching features of AVXL and NTRP.
" P2a is for safety not efficacy".
Correct: (secondary endpoints can only , of course, provide wishful hits at unsubstantiated efficacy in the P2a because it's designed to show safety not efficacy.)
NTRP has actually already completed a P2a for safety (in fact the drug has proven safety in MULTIPLE previous trial for other indications and at higher doses.)
The pending results for NTRP will be P2B results. They actually include efficacy in the "Primary Outcome Measures"
Primary Outcome Measures:
Safety: Treatment emergent Adverse Events and Serious Adverse Events [ Time Frame: Primary analysis after 12 weeks of treatment ]
Efficacy: Change from baseline in Severe Impairment Battery (SIB) [ Time Frame: Primary analysis after 12 weeks of treatment ].
The estimated enrollment is 150 people. It even includes blinding and placebo controls like a real "big boy trial" that has a possibility of failure.
"Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind,Placebo-Controlled, Phase 2 Study Assessing the Safety, Tolerability and Efficacy of Bryostatin in the Treatment of Moderately Severe to Severe Alzheimer's Disease
AVXL actually is the company who only has 2a data. It's from only 32, well 27, patients, its also unblinded,non placebo controlled and not powered for statistical significance. No one seems to know or even care how those dropouts are represented on the graphs being touted at these "scientific conferences" that some place so much value in.
Investors here should pay close attention to the results and graphs that NTRP provides when they release the results. It's very tempting for these companies to carefully manipulate the data to fool unwitting retail investors into misinterpreting what the graphs actually represent. I have seen it happen.
There are many moving parts that must all fall into place for investments like these two to make investors wealthy. I hope it works out for both, but both companies are long shots and it is an extremely risky place to bet the farm imho.
