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Carboat

06/22/16 6:55 AM

#267114 RE: Protector #267113

So they did not "file a BLA". Maybe some partial filings but they of course did not, and will not, file a (complete) BLA.
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hopefilled2014

06/22/16 7:05 AM

#267115 RE: Protector #267113

CP, bavi given a lot of coverage in this 2-pager on I/O. Notice that P3 "faltered" a much richer and honest appraisal of that trial ending than given by some here. Also this...

Gabrilovich is involved in several clinical studies focused on MDSC strategies, although he did not want to discuss the details of those efforts.


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north40000

06/22/16 9:19 AM

#267124 RE: Protector #267113

Do you recall Dr. Garnick saying those 500k "pages" would fill a few trucks if paper, rather than in electronic, digital/analog format?
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Dragon Lady

06/22/16 10:27 AM

#267129 RE: Protector #267113

Slide 34 SAYS NOTHING, just generic info..

IMO, it's crystal clear- the slide is GENERIC, GENERAL speaking info. NOTHING specific to PPHM in it???

NOWHERE on that slide is it even implicated that PPHM has/had a "BLA" or a "CTD" even written or prepared.

It's a generic slide explaining WHAT A "BLA" is- from the industry/FDA standards. It then explains what one consists of- NOT that PPHM had one or has one or was even working on one yet. It's stating WHAT IT "WOULD" take to prepare one, NOT that one had/has been prepared.

It makes a generic statement that when read in that context, merely is stating that "on average" these filings run approx 500K pages. NOTHING else is stated on that slide.

IF, PPHM had the imaginary "electronic filing" already prepared and had submitted it- it wouldn't be "approx X number of pages", they'd know EXACTLY how many pages long it was.

Again, the slide is generic info anyone can find on the internet, from the FDA, from any consulting firm familiar with submitting - and they'd say something similar such as, "Those filings run on AVERAGE "APPROXIMATELY" about 500K pages per the industry standards", something to that effect.

That slide 34 is a big ole ta-doo about NOTHING to me. It's public available, industry known, GENERIC freaking info. Presented IMO, simply to emphasize to the audience being spoken to, in order to give a size and scope of the effort (and obviously large expense required) it takes/would take to prepare and submit filings, IF and WHEN a company were to undertake the effort (NOT A SHRED, NOT ONE WORD, NOTHING on the slide says that PPHM was already undertaking such an effort in the info on that slide, let alone does it say they held 500K pages of prepared filing documents- not that I can see or read????)