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Ready4bluesky

03/03/16 1:51 AM

#55809 RE: flipper44 #55807

No I didn't forget this (once again courtesy of beartrap12) as of December 18th:

"She said the trial is close to completing enrollment... that enrollment would be done about January, or February."

I'm sure this was best case scenario, you know, if the screening hold were lifted in short order like they hoped. But it hasn't been and there's no reason to believe enrollment is complete.

Haha, don't trip over yourself backpedaling. You went from "clear that the trial was fully enrolled around Halloween" to "sufficiently enrolled" (whatever that means). I prefer to believe Linda.

Pyrrhonian

03/03/16 8:19 AM

#55814 RE: flipper44 #55807

They're probably only at 305. 6/7ths enrolled can be construed as "very close." You should all remember the ways in which management have skewed the facts in the past. "Increased the trial a little bit" and "by 36 patients," both lies, really.

Not sure where all the unapologetic TRUST comes from here. All I can think of is these investors must not have a lot of experience in dealing with micro and small cap bios. I was no exception to that at one point. Neither was Adam F who has invested in them in the past and lost money. Something really should be done about these companies and the way they mislead, but, you know, the SEC is busy I guess.

You can find a number of little lawsuits but they're usually swept under the rug. One bigger one that reminds me of NWBO is British Biotech. Some interesting stuff in here:

https://www.sec.gov/litigation/admin/34-41505.htm

Reminds me a bit of the necrosis stuff with Direct. Of course FDA doesn't give a damn about necrosis, and it's not really been shown to have a real clinical benefit, except in some cases of absolute necrosis such as with radiofrequency ablation. But then of course, that's already a thing, so--who needs Direct? No systemic effect has been shown with Direct as yet. And then we have T-VEC out now, so... I just don't see a future for Direct. JMO.

Anyway, back to enrollment. I did read Kabanushi say he talked to Les and they are hoping to enroll again soon. And then Drum said (and admitted being nervous about) there may be something that further delays the conclusion of the study. Let me find that


"Discussions centering around the halt and whether it will significantly impact/delay the L trial beyond 2016. Les clearly stated that this depends upon the review of data which has been submitted. The trial could continue as is to completion (implication is minimum delay as LP has previously stated) or something else." -Drum



I mean for me that really could be what AVII and I have been talking about. Changing the trial for OS. Or at least trying to. They may get denied and then who knows how they proceed. They could of course finish this trial and hope for the best, knowing AA is off the table and so even if PFS is SS they have to run another P3 anyway.

All of the above are reasons enough to get outta here, imo. Yes, even at $1.70! Just much clearer, better places for what's left of the money. Which is all you really can be sure you have now.

GL


Smokey21

03/03/16 8:52 AM

#55820 RE: flipper44 #55807

When I spoke to Larry the other day, he referred to having a 6 month pipeline after screening, which I took to mean enrollment could continue for up to 6 months after screening. Which could imply enrollments continuing through January, despite the screening hold. That came up in response to my question on cash burn rate with the L enrollment hold being in place and Direct trial not yet enrolling.

austinmediainc

03/03/16 9:29 AM

#55828 RE: flipper44 #55807

I contend it was likely sufficiently enrolled, LP stated it was very close to complete enrollment according to someone's notes. Or did you forget about that. I think that is the conclusion Drummword just drew as well based upon his discussion with Les. The process was wise to use a partial screening halt at that time because if need be, they can reopen enrollment for either an expansion, if necessary (again precaution), or for confirmatory enrollment if the same trial is converted to a confirmatory trial.

Weren't we supposed to be fully enrolled in 2014, with topline results early 2015? Weren't we supposed to start the Direct phase II, two years ago? Weren't we supposed to be booking revenue from the German HE patient pay? Didn't we screen the first patient for this program 1.5 years ago with a waiting list of patients to go? Wasn't HE and EA supposed to speed things up? Weren't they in discussions to partner the Prostate Trial?

Everything here is pure speculation.....because the company doesn't provide the details to know the answers. But I'm sure that's just to protect the investors from the shorts.....