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Biotech / Medical : Provectus Pharmaceuticals Inc.

PVCT 0.0700

+1.4%

Nov 21 3:07 PM EST

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To: NTTG who wrote (11604)

10/18/2012 8:05:05 PM

From: LT2011

Read Replies (2) of 13111

NTTG I came across one of your posts from earlier this year and I thought today would be a good day to ask you to restate your projected time line for PVCT.

The last 2 sentences of the first paragraph was very interesting and now a little scary.
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To: jm2i123 who wrote (10865)	2/22/2012 10:21:54 AM
From: NTTG	4 Recommendations of 11605

Fair enough.....Assuming they get a SPA designation (last company PR still confirms that both options are on the table...there is no lock on an SPA http://www.biopharmphysicians.com/special-protocol-assessment-a-blessing-or-a-bane/ ) then the review process is cut to 45 days...Study site IRB review time and logistic ramp up time is the same...so they could start in Q4 of 2012. Still project 3 years to accrue patients based on company experience with PII and other company experiences running their MM PIII trials. (will assume no delay in getting Not sure where 3 years of $$ will come from, but let's assume they can get the cash Last patient in Q3 2015 at the earliest.... follow up observation per protocol (likely 6 months to a year for final data collection of mortality outcomes). For 6 months last data is into the database end of Q1 2016. Still suggest a year to analyze and write Executive summary and NDA...Q1 2017...... then submission and review in 2017 with projected approval in late 2017 to early 2018...assuming everything goes like clock work. SPA gets you a little time advantage at the from end...but does not impact the bulk of the study cycle timing.

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