"I beg to differ with everybody (as usual). This company has set itself up for a BINARY P1 result, dependent on, of all things, EFFICACY."
ok, first a pet hate, HC's favorite new cool phase - "the binary event".
A binary event is where one of ONLY two possible (per-determinable) outcomes can happen. On or off, zero or one.
Binary is base two (one of two). Our phase 1b result has an infinite number of outcomes. Different levels of effectiveness, safety, effectiveness duration, alteration etc - as well as the wording of the such result.
But moving on, the phase 1b is about safety and dosing selection. We have been told we have both, so effectively we have passed the phase 1b. Further proof comes from the fact that the company states that the phase 2 is going ahead, so the phase 1b must be successful.
But, our phase 1b is also looking at efficacy. The company has stated that ALL subjects have had an immune response & are producing their own antibodies - so there's a massive amount of proof of efficacy there.
This is a big difference to the other billion dollar therapies, as the antibodies are synthetic and given to the patients. With imu's product the patient produces their own antibodies.
So this is a major point of difference, and one to look at further.
Producing your own antibodies would logically be safer - and from what we have heard it is, with no safety issues at all. But is it as effective? Well Mayo's own B cell therapy is effective, so that shows that the B cell therapies can work.
With Herr-vax the company has stated that in models it is much more effective than the big selling Heceptin. So, given that B cells do work, are safe and our Herr-Vax formula looks fantastic, we could well be on to a winner.
Cheers
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