"What Adam Feuerstein really said about MSTX phase 3 trials
1. That two specialists are successfully using Vepoloxamer.
2. That an investor he knows, but not calls by name- an eskimo who spends money on Wall Street is an investor too- says he doesn't think (read 'think') Vepo will pass...
3. There is almost no risk in buying shares of MSTX b/c failiure is already priced i
4. There is absolutely no mention of the beneficial effect of hydroxyurea (used in more than 60% of the patients).
5. Adam F. doesn't mention the average age is 15 years, and VEPO has showed superior efficacy for mean age under 16 years
To summarize my opinion: The previous failed phase 3 trials score a modest efficacy with p=0.07, efficacy, so with the largest trial ever on sickle cell, more than 60% hydroxyurea and mean age below 16y, I think the chances will be high to score statistical efficiency with p below .05
With the changed study variables: age, hydroxyurea,the number of participants they only need to move p=.07 towards p=.05 or move from modest efficacy to statistical significant efficacy."
Author Alexander.johannes and Annicka Waechter from Yahoo finance
"Perfect...the conversations about opiates, SCD and the FDA...
This is one of my main points when corresponding with friends and associates in the medical and scientific communities.
The FDA has a underlying objective to rid the US of it's reliance on opiates. If you are a SCD sufferer...you are condemned to be an opiate addict. PERIOD. The pain is too intense that there is no way to off stave such a condemnation.
AF has no clue as to the FDA's secondary objective here to off stave the social ramifications of this disease.
Glad to see this HUGE note finally mentioned here...and so sorry to not have brought it up previously...being that such is a HUGE point.
There has been a lot of speculation on this board...but much of which is highly informed (Culley being Culley Besides). If this passes...he will be a rock star. If it fails, a monster.
The FDA and opiate concern is a big deal and if our results are even remotely "good"...we will have a huge friend of the FDA"
Author bpy03 on Yahoo finance
