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OK, thanks! EOM
Easymoneyman, I don't think we have any disagreements.
Clearly ADXS has to produce convincing clinical results before
any of us can assume success (but probability for me is high
enough for a pretty significant investment).
The other point I was making, based on observing the
regulatory path Ponatinib (Ariad) was traversing, is
that as an outsider, I knew enough about the efficacy
of Ponatinib, that I would have insisted on taking it early,
rather than Gleevec, then a series of others, with a very
good chance of relapse. In other words, CML patients are forced
to run the gauntlet of three SOC drugs in sequence, before
they are allowed to get the drug that has the best chance
of knocking out the cancer decisively.
My only point is that there is a level of regulatory hurdles
that work against the patient's benefit. I think Dr.Gottlieb
said as much, and his initiatives at the FDA are designed
to remedy just that issue.
Thanks, the real benefit is having someone as
experienced in this area as hovacare, who is willing to
contribute to the conversation.
My "misconception" (which in fact may be a misconception) is based
on my experience watching Ariad's drug, which was in fact very
effective, trying to get past what seemed like a malevolent FDA
bureaucracy, while many patients were dying, and could have been
saved. Years were lost.
Another current case is Aurinia's drug, Voclosporin, which has
had a stellar P2, and is now going into P3, double blinded, and
the end results not available for two years. If I had Lupus Nephritis
I would want that drug now, in two years I might be on dialysis.
Unfortunately, "current standard of care" is as much determined
by lawyers as physicians, and with the patient having the least input.
I'm hoping that Dr.Gottlieb will be pushing really hard to change
that.
I will regretfully concede to your greater knowledge of
this situation (with a bit of hope that doctors will be
made aware, with perhaps some publicity promoted
by the company).
BTW, I really appreciate your comments, always reasonable
and well informed.
Sounds good, Thanks! EOM
Boilerplate garbage!!!!
Can anyone find anything relevant to ADXS in this:
How to build a straw horse, then demolish it!!
The "researcher" says that Dr.Gottlieb will not intervene
to halt Vocl. P3 (to make it available to patients NOW!!!).
Of course not!!!
He (the researcher, LOL) chose to (mis)interpret the obvious!
Nobody meant that he (Dr.G.) will personally march over
to Aurinia headquarters and announce the good news.
NO, not at all! OBVIOUSLY!!!!!!
What I meant (and others meant) is that Gottlieb brings a brand
new policy of helping patients get new drugs sooner, it's a policy to
curb the abuses of the FDA, it's a new policy that favors
innovation, as opposed to crushing small biotechs, in
prolonging clinical trials to the point where BP can step
in and scoop up financially exhausted innovators, and
denying the rewards to the investors who financed the
research, and took the risks in the first place.
Am I explicit enough, or do think I'm still in "over my head" LOL!!!!!
Exactly how I feel! EOM
Julius, thanks for getting at the deep essence of tinfoil's
posts. I've been struggling to understand it, and your
summary pretty much captures the full diversity of thoughts!
Here's a recap:
What is "interesting" about tinfoil's "theories" is that they
are non-company specific. In other words, he can cut
and paste the exact "theories" on any other small biotech
board when he decides to "contribute" someplace else.
Now that's what I call efficiency!!! LOL!
Hi grandma!
Not so, I read your posts as well. I like your intuitions on
picking a good investment (with a little help from vidpok,
at least for me), AND your dogged stubborness in sticking
with your convictions. It's not a guarantee that it will work
out, BUT is sure did with Ariad, and I believe it will also
have similar results here (minus the drama there).
I cannot think of another biotech where the probability
for a favorable outcome is as good as AUPH. The people
running the show are top notch, have deep experience in
both the specific science (LN related issues), and the
business acumen based on a very similar (almost
the same) medical and business situation.
While it might take two years for approval, I think we'll
see upward movement before that, after all, Aurinia does
have other indications for Voc. and potential for deal-making.
Good luck to you and fellow longs,
zzaatt/amp
PS: This two year (blinded) wait seems pretty grotesque, given the
strong results in P2 and the fact that it will cost the lives
of thousands of very desperate patients. I always had a
profound contempt for the corrupt, hide-bound bureaucracy
known as the FDA and I'm hoping for big changes under Dr.Gottlieb!
Who knows, maybe some conditional approval may be possible,
it certainly should be, if the goal is to help sick people.