You want infection stats for post approval?.. The FDA wants some post approval data too.. From Braeburn's S1.. " The FDA has required that we conduct four post-approval clinical trials to assess the insertion, localization and removal related serious adverse events of Probuphine, the risk of the QT interval in the heart's electrical cycle during treatment with Probuphine, the effect of scarring or inflammation related to a prior implant on the safety of re-implantation / reinsertion,the potential for implant migration, and the bioavailability of Probuphine into the same insertion site, and the safety, feasibility and pharmacokinetics of Probuphine implantation at alternate body sites.".. I haven't heard TTNP speak recently about results from these tests..(maybe I missed it)… given their burn rate not sure they will have enough funds till the end of 2018, regardless of their vague "we believe"… the loan terms are austere as TTNP has to shell out 665K in interest/yr.. By March 31 2018, in order to get the 2nd tranche of 3 mil, they are required to: 1. have a market cap of not < than 50 mil.. (Price has to climb north of 2 to come close)…2. report revenue from royalty not < than 750,000.. (Is that possible?) 3. Signed Partnership Probuphine Europe… (Maybe)…TTNP'S best hope is to sell the company to stronger hands as soon as they can or the sharks will circle and take the intellectual property at a fire sale… what TTNP management has shrouded in non-disclosure and generalities, the Braeburn S1 laid bare, & the price has been tanking since then… yes there is promise in the technology but the partnership w/Apple Tree was a poor choice as demonstrated by their failed attempt to market Probuphine to sole proprietor docs w/a high price point as though it was a pill they could prescribe, instead of the insurance nightmare that many sole proprietors can do without.. Braeburn missed going directly for market penetration to the VA, HMO's, jails & prisons who are not reliant on insurance reimbursal as they are self-funded.. Ultimately we all wait for that post approval data to help us make an informed decision about this product
