Seel, what exactly is happening with the various K
Post# of 72440
Seel, what exactly is happening with the various Kevetrin trials planned for U of B, MDA, BI, etc? Are they beginning/already begun pre clinical trials and if positive results are evidenced they immediately begin phase II clinical trials once MTD for Kevetrin established? How lengthy a time is normal to get FDA approval for a phase II trial? As for U of B, I am under the impression they have already run pre clinical animal trials and had very positive results (which U of B plans to publish so CTIX has agreed to sit mum on results) and only have to wait until Kevetrin MTD found to begin human testing; I thought this scenario is also what is occurring as to the Kevetrin- Sunitinib renal compound being tested at BI.
Would MDA have enough time between now and the end of the year to get most of their data regarding pre clinicals in order to be able to hit the ground running in early 2014 once Kevetrin MTD established?
What is the expected time frame for phase II trials to show efficacy (or at least the start of efficacy), just two or three cohorts?
Do you expect the Breakthrough Therapy Phase II trial for retinoblastoma on infants to be the first of the phase II trials getting started as CTIX has already mentioned how eager they are for this phase II to get started on an expedited basis?
TIA
Pete