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Biotech / Medical : Provectus Pharmaceuticals Inc. -- Ignore unavailable to you. Want to Upgrade?

To: boomertree2 who wrote (11961)5/22/2013 11:06:31 AM
From: NTTG1 Recommendation  Read Replies (1) | Respond to of 13111
 
And these limitations were recognized years ago, nothing new.



To: boomertree2 who wrote (11961)5/22/2013 3:11:29 PM
From: Howard Williams1 Recommendation  Respond to of 13111
 
boomertree2, IMO the best (fastest/cheapest) path to accelerated approval or Breakthrough Designation would be via the simplest Phase III design that shows efficacy (with safety) for adequate to support either of those highly desirable options. And the Moffitt data can seal the deal.

Argarwala's statement almost explicitly telegraphs that ...... "Right now we consider such a response [the bystander effect] to be a bonus clinically."



To: boomertree2 who wrote (11961)5/22/2013 6:51:23 PM
From: Jack Russell2 Recommendations  Read Replies (1) | Respond to of 13111
 
Boomer I am not sure how it matters as long as they get through the trial? I would think as Argwala stated that after the trial it would be a bonus. Why make the trial more difficult? get approval move on and yes the bystander effect is a great bonus after the fact and after approval.


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