InVivo Therapeutics provides update on scaffold trial


InVivo Therapeutics (NVIV) issues a PR saying its degradable polymer scaffold trial will "be ready to enroll patients in Q1 2014."

The company also says it "will submit a filing containing proposed changes to its FDA-approved protocol and supporting documents within the next ten days."

NVIV thinks the changes, if approved, would "accelerate the progress of [the] trial by eliminating barriers to enrollment and by expanding the number of sites from at least three to as many as six."

Additionally, the company says it has temporarily suspended "most work" on hydrogel in order to focus on scaffold manufacturing. NVIV says it has "entered into discussions with a number of prospective corporate partners based on this new business model." (PR)

Comments (3)
  • Esekla
    , contributor
    Comments (4478) | Send Message
     
    I warned repeatedly in comments about NVIV's valuation when it was in the $5 and $6 range, and then pointed out that Reynolds leaving was a good thing over the long term. I've accumulated stock as he's dumped shares, which was temporarily depressing the stock price. I'd guess it's all upside from here.
    15 Nov 2013, 11:50 AM Reply Like
  • rx7no1
    , contributor
    Comments (17) | Send Message
     
    But if the FDA protocol still requires a three month delay between each patient treated it won't matter how many centers available to use the scaffoldit will be close to a year and a half before enough patients are treated and evealuated before we could get a Phase II going.
    Our best hope is that the first patients show remarkable,
    irefutable improvement above base line and force the FDA to allow an expedited program.
    Also to get the hydrogel back on track to get into a trial uneder way before the end of next year.
    Under Reynolds the company NEVER met promised deadlines and the minute this new management misses one of theirs there will be a collective blast of disgust from us long holding long abused shareholders.
    15 Nov 2013, 04:40 PM Reply Like
  • bufnyfan1
    , contributor
    Comments (216) | Send Message
     
    Bringing in Mr. Astrue was probably the best thing that could have happened--he has experience/contacts within the FDA that should easily obtain approval for this change in the scaffold trial protocol--and I bet he has a "rolodex" full of contacts within the biotechnology community that will make a partnership for the hydrogel technology easy (my bet is In Vivo will agree to a royalty payment for the sales of this)
    16 Nov 2013, 09:45 AM Reply Like
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