Let me address this one by one: 1) The is now NO
Post# of 72440
Posted On: 09/11/2013 2:04:45 AM
Let me address this one by one:
1) The is now NO scheduled Prurisol trial
You don't know that. In fact, in the transcript Leo does imply there is a NEW schedule and accoring to BJ the EU site is still part of it.
2)The scheduled Prurisol trial has been replaced with some ongoing conversation with the
FDA that has just begun and might take months...none of the hot dogs who attended in
in person had the presence of mind or common sense to ask LEO for a timeline on that
Again not true. There is no conversation. They are going straight to filing an INDA with the expectation of starting at Phase 2 and possibly and expanded Phase 2/3. Menon would NEVER have done this without first consulting with their FDA contact. They have already done a pre-IND and the recommendation was a bridge study followed by Phase 2/3. They decided to make that bridge study a PoC to raise awareness and funding opportunities but in the transcript Leo makes it clear they now have the funds to skip the PoC AND develop the Phase 2b for B.
3) The report of current dose being at ONLY 75mg indicates the Protocol has been changed
behind the scenes with NO updating of the published protocol or notice to shareholders
other than the announcement of 9/9 while mgmt has known since around the time of
of ASCO.......this is an integrity issue as far as I am concerned
One more time,wrong. There was no change in the protocol. Dose escalation includes absolute safety first and in the first 4 cohorts there were minor issues that may or may not be caused by K, but it slowed the escalation. You say only 75 mg/kg^2 but that is at the lowest end of efficacy range. As TOB pointed out, safety and low end efficacy has already been established. It's a positive, not a negative.
The rest of your post isn't even worth comment because it's just a pile of melodramatic bullshit.
1) The is now NO scheduled Prurisol trial
You don't know that. In fact, in the transcript Leo does imply there is a NEW schedule and accoring to BJ the EU site is still part of it.
2)The scheduled Prurisol trial has been replaced with some ongoing conversation with the
FDA that has just begun and might take months...none of the hot dogs who attended in
in person had the presence of mind or common sense to ask LEO for a timeline on that
Again not true. There is no conversation. They are going straight to filing an INDA with the expectation of starting at Phase 2 and possibly and expanded Phase 2/3. Menon would NEVER have done this without first consulting with their FDA contact. They have already done a pre-IND and the recommendation was a bridge study followed by Phase 2/3. They decided to make that bridge study a PoC to raise awareness and funding opportunities but in the transcript Leo makes it clear they now have the funds to skip the PoC AND develop the Phase 2b for B.
3) The report of current dose being at ONLY 75mg indicates the Protocol has been changed
behind the scenes with NO updating of the published protocol or notice to shareholders
other than the announcement of 9/9 while mgmt has known since around the time of
of ASCO.......this is an integrity issue as far as I am concerned
One more time,wrong. There was no change in the protocol. Dose escalation includes absolute safety first and in the first 4 cohorts there were minor issues that may or may not be caused by K, but it slowed the escalation. You say only 75 mg/kg^2 but that is at the lowest end of efficacy range. As TOB pointed out, safety and low end efficacy has already been established. It's a positive, not a negative.
The rest of your post isn't even worth comment because it's just a pile of melodramatic bullshit.
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