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mjw007

10/21/17 8:07 AM

#1525 RE: staccani #1524

Thanks for posting
Your thoughts re EMA designation and language?

Not sure why it took them so long to announce this news

On Friday, I thought we might end up closing back in the mid to high 6 range, but unfortunately it sold off again

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gr8db8

10/21/17 12:50 PM

#1527 RE: staccani #1524

My take away is that a medical committee reviewed the data and found it compelling enough to grant orphan status.

Here is the background for the COMP coordinator:
http://www.ema.europa.eu/docs/en_GB/document_library/contacts/bdaum_CV.pdf

The committee consists of medical professionals with similar backgrounds. Their vote, imo, is significant because in order to get the designation, they get an up close view of all the data and immediate answers to any question that they may have.

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gr8db8

10/21/17 1:03 PM

#1528 RE: staccani #1524

"The sponsor has provided preliminary clinical data that demonstrate that treatment improved survival in recurrent platinum-resistant patients. An indirect comparison was conducted to show that the survival benefit compared favourably with the survival observed with authorised products. The Committee considered that this constitutes a clinically relevant advantage.

A positive opinion for ofranergene obadenovec, for treatment of ovarian cancer, was adopted by consensus."

The last part is also a nice read.