RAT Designation, page-2

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col69

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21/05/17

12:54

Post #: 24818610
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Originally posted by The Yankee ↑

You might recall Vericel receiving FDA fast track designation on February 21, 2017.
They subsequently also received RAT designation on May 10, 2017.
This is for their i-xmyelocel-T treatment for advanced heart failure due to Ischemic Dilated Cardiomyopathy.
They also licensed their product portfolio to (Innovative Cellular Therapeutics) ICT of China.

This despite only completing a Phase 2b study. The study failed in its secondary end points. Yes, you read that right.

As I have been saying all along, the RAT designation can be given (and is being given) after completing just a Phase 2 trial. So how many of Mesoblast's therapies can get the RAT designation? You know the answer.

As to why Mesoblast has not received the RAT designation yet is a question I wanted to ask the company. I called Mesoblast Australia yesterday but could not get IR or anyone to take my call (the IR in the US is useless - they never respond). Hope Melbourne returns my call.
My guess is that Vericel got the designations straight away because their therapy is autologous as opposed to allogeneic.

In any case, my last conversation with Julie Meldrum gave me the impression that they are pursuing the RAT designation (yes, even for GvHD which already has been given the fast track designation) for several treatments.
Folks, I believe Mesoblast will get the RAT designation any day now.

PS: I find it amusing that some even respond to the post by "DerekT". I got a good laugh from it. Perhaps all the longs should sell their shares, based on the "evidence" he uncovered?
SMH.

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Howdy @The Yankee

I sent MSB an email last week asking some questions about RAT Designation as well so hopefully one of us gets some feedback soon

GLTAH

MSB Price at posting: $2.38 Sentiment: Hold Disclosure: Held
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