Biotech Forecast

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  1. Do you want to share your biotech stock trading knowledge and gain access to advanced tools? If yes, contact us to become an advanced member. Benefits and characteristics of advanced members are: Advanced members are those member who have taken our course and show good knowledge of biotech investing. You are given more tools to track events and customize content. Can create a blog and write engaging content for whole the community to enjoy. Enter events into our Biotech Event Tracker and then follow these events in your activity stream. Create, edit and update these events as they happen.
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  5. The PDUFA date of May 29th, 2016 has been added to the event tracker. As a reminder, the company will have to do a confirmatory phase 4 trial per the requirements of the FDA accelerated approval.
  6. Press release on March 29th indicates phase 2 results will be released in the second half of May 2016: TNX-102 SL – PTSD Program Tonix is also developing TNX-102 SL, the same proprietary product candidate as Tonmya, for daily use at bedtime for the management of PTSD, a chronic condition. In December 2015, Tonix exceeded full enrollment of approximately 240 patients with military-related PTSD in the randomized, double-blind, placebo-controlled, 12-week Phase 2 AtEase clinical trial of TNX-102 SL. Tonix expects to report top-line data from the AtEase study in the second quarter of 2016. The primary efficacy endpoint of AtEase will evaluate the performance of TNX-102 SL 2.8 mg as measured by the mean change from baseline on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). In December 2015, Tonix signed a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Medical Materiel Development Activity (USAMMDA) to explore expansion and potential development of TNX-102 SL for the treatment of military-related PTSD.