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TC_Trader

05/04/16 6:18 AM

#60567 RE: notbrad #60561

Yes
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Dan88

05/04/16 8:31 AM

#60571 RE: notbrad #60561

Yes, I saw that too. Let put this way: Linda did and has been asking something, maybe too many things, and FDA has been a bit annoyed as I put in my "Hijack Theory." And the company still is providing further information to regulatory bodies as of 2 May.

As we have said many times there is definitely some thing going on behind scene.

One question, why the company doesn't spell out the number of enrollment it actually has had as of 2 May, instead still letting anyone guessing. This time it said, "well over 300," why not said, about 318 or approximately 308 or 328, etc.

So the number is an issue too?

Even if the L is approved this time, $1.36 a piece is a joke, but I understand it has something to do with the way the company does its business.

But $1.36 or $30? It is a simple question, doesn't it (the last two paragraphs are not a question to you notbrad, and thank you for your input).
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Smokey21

05/04/16 10:12 AM

#60578 RE: notbrad #60561

Also, right after that:

"preparations for Phase II trials with DCVax-L and DCVax-Direct"

So, it would appear that one of those Phase II (CI combo) trials they spoke of in their operations update is with DCVax-L
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sentiment_stocks

05/04/16 10:18 AM

#60579 RE: notbrad #60561

Good find... any ideas as to what might be considered "major" in a regulatory submission that might increase their operating expenses?

Considering the "hijack" theory of Dan's... it's been thrown out there previously, initially when Flipper found "The Cancer Letter" interview of Dr. Pazdur... but Dan used the word hijack, which I kinda like.

Anyway... just a thought... what if the FDA did take a thorough peek at the trial data, didn't tell the company what they were looking at in order to keep the blind on...

(Linda L. states they were still blinded as of October 15 - remember, that's the day that her fellow academics furtively called all their hedge fund buddies telling them to sell NWBO after she spoke bullishly on L's progress - according to Adam)

... and then asked the company to make some sort of "major regulatory submission(s)"?

One thing that's been rattling around in my head... is what if the FDA requested that all the trial patient's tumors (presuming there was something left after the vaccine was made) be tested via deep sequencing of the T cell receptors by Adaptive Biotechnologies? If the FDA peeked, saw some patients were living much longer than normal, and wanted to know what might be different with those patients from those who weren't living as long?

I'd think that would be pretty costly. Not that your typical regulatory submission wouldn't be expensive. It was just a thought.