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Re: Honeycomb777 post# 96079

Monday, 09/16/2019 5:29:40 PM

Monday, September 16, 2019 5:29:40 PM

Post# of 140474
Oh there is a rush alright and an urgency for the shorts - their target is $1 so they better get in soon b/c Q4 is right around the corner and that is when the FDA will give its approval and sign off on Titan's IDE.

As for Sept 24th, ONLY 5 trading days away. Medtronic will be showing their hand and HOW THEY PLAN TO COMPETE WITH INTUITIVE SURGICAL. They will need a SINGLE PORT SURGICAL ROBOTIC PLATFORM, as well as multi port and endoluminal. So what will they show, IF THEY DO NOT HAVE A SINGLE PORT YET that will increase Titan's value exponentially. If they come out with a psuedo SINGLE PORT platform that isn't Titan well then the party is really going to start. The next question is what does JNJ share on Sept 24th and if not then, how soon before they show their hand?

IDE approval is FDA approval

https://www.fda.gov/medical-devices/device-advice-investigational-device-exemption-ide/ide-approval-process

Studies of devices that pose a significant risk require both FDA and an Institutional Review Board (IRB) approval prior to initiation of a clinical study. FDA approval is obtained by submitting an IDE application to FDA (§812.20)