Thursday, April 24, 2014 10:26:35 AM
"[In this type of first in man trial,] initially FDA requires you to go very slowly. You have to treat one patient, you have to treat them several times, wait several weeks, and then you can treat another one patient, and so on, but you have to go through what we refer to as a 'slow period.' I'm happy to say we are coming near to the end of the slow period. The slow period takes you through three dose levels. And we have filled the first two dose levels with patients, and we will be filling the third dose level over the course of this Spring... We are not going to be announcing data about the trial yet, but we have submitted an abstract to ASCO..., and if it doesn't jeopardize our ASCO application we may mention a bit later this Spring."
Apparently flipper prefers a more incognito form of posting these days ;)
Afford:
--Cash is always desperately needed to finance their programs and manufacturing. They can only secure financing using what is publicly available, and presenting this to financiers. Management has to walk a fine line in divulging information when securing financing. The terms, imo, were quite good.
--When dealing with running a double blind trial, and another that has embargoed data, I'm sure appearing this way is unavoidable.
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