Once in a while--hat tip to Fan YMB

[biopearl123]

Once in a while Fan on YMB comes up with some interesting information as a result of his or her diligent digging. In this case the following:

https://8c3e11d9-5f36-452f-abe3-c95befd ... 5d1056.pdf

Check out the verbiage under "evidentiary requirements". Interesting, especially in light of Dr. Scarlett's emphasis on continued validation of manufacturing capabilities in the last call. bp

[LWS]

Very interesting -------The wording from the EMA for OD status needs to be compared with the FDA wording. Is it possible that OD status from the EMA, from a practical point of view, implies much more than the FDA wording. Does the EMA OD status imply that the next step or approval will soon follow (historically)?

[kmall]

LWS - not sure about the answer to your question regarding EMA OD leading to approval as the next step, however, this touches on FDA and EMA OD comparisons. Of note, only 41% of those cancer drugs who get FDA OD also are granted EMA OD. Hopefully a good sign for Imet.
https://www.google.com/url?sa=t&source= ... 6953692919

[rccola335]

The percentage of drugs that get EMA OD that go on to get MA is not great - I would attribute this to getting OD early on in the process whereas the Orphan for MDS is later in the process where there is excellent mature data to support MA - also remember there are less options for patients for MDS in Europe than the US

[ashah]

A wild thought.
Given the "brighter" regulatory prospect in Europe, would it not make better value for shareholder (better negotiation position) to defer the formal EU partner selection till a Marketing Application in EU is filed?
Or at least further along the process versus announcing the EU partner by an artificial date of this year?