TSLA
Tesla
-- 421.060 NVDA
NVIDIA
-- 134.700 PLTR
Palantir
-- 80.550 AMD
Advanced Micro Devices
-- 119.210 OXY
Occidental Petroleum
-- 47.130 
FDA Development Paths
1️⃣ Standard Designation: Standard designation is the typical pathway for drug development, involving preclinical studies and three phases of clinical trials to assess safety and efficacy thoroughly.
2️⃣ Orphan Designation: Reserved for drugs targeting rare diseases, this designation offers incentives like tax credits and marketing exclusivity to encourage development for underserved patient populations.
3️⃣ Fast Track Designation: Fast Track expedites drug development for serious conditions with unmet medical needs, allowing more frequent interactions with the FDA and potential for accelerated approval.
4️⃣ Accelerated Approval: Granted based on surrogate endpoints for serious conditions with no effective treatments, this pathway enables quicker market access, with post-marketing studies required to confirm clinical benefits.
5️⃣ Priority Review: Reserved for drugs offering significant improvements over existing therapies for serious conditions, Priority Review aims to complete the FDA review within six months, expediting access to promising treatments.
6️⃣ Breakthrough Therapy Designation: Reserved for drugs showing substantial improvement over existing therapies, Breakthrough Therapy status expedites development with FDA guidance, aiming to bring innovative treatments to patients faster.
Source: Nicolas Hubacz via Camila Fedi on the HR App!
Disclaimer: Community is offered by Moomoo Technologies Inc. and is for educational purposes only.
Read more
Comment
Sign in to post a comment
Salmon Klein : are you in $Macrogenics (MGNX.US)$ ? tell me when good to jump in
MangoXoXo Salmon Klein : Now
Iwill TradeScared Salmon Klein : Do your own research , I think hovering in bottom and buy signal from pattern about to begin , do not follow me blindly my
Salmon Klein Iwill TradeScared : I am waiting to reach 14.8 or so, but I am busy working, if it reached the bottom and you are in...any good feedback is always very welcomed bro...just that so thanks
Iwill TradeScared Salmon Klein : Double higher bottom in intra-day might not hit below 14ish or if so still chance for 2 more trading sideways days, I am almost 25% down ( reason holding beyond top) anyway