Replies to post #95972 on Titan Medical Inc (TMDIF)

[RockoTaco]

Whenever JNJ is ready to move on it.

[West Coast Snapper]

Commercialization? First the product has to get re engineered. Then file IDE. Then get approval for IDE. Then manufacture the product. Then do human testing. Then submit data to FDA. Then hope for FDA approval. Oh. And the company runs out of cash in November and needs $10M a quarter to survive. So need $50M by end of 2020. Then they can commercialize

[elMoose]

The company is on the track of applying FDA approvals next Q.

From their presentation.

Established US & EU Centers of Excellence 2018
Proven Feasibility 2018
Integrated Simulation Training 2018
Engineering Confidence Build 2019
Design Freeze 2019
Commence GLP Animal Studies 2019
IDE Approval Q4 2019
Submit 510(k) Application H1 2020
Submit Technical File for CE Mark H1 2020
Anticipated Regulatory Clearance H2 2020
Projected Initial Launch H2 2020

https://titanmedicalinc.com/wp-content/uploads/2019/09/Titan-Medical-Investor-Presentation-September-4-2019.pdf