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Jhawker

03/06/14 4:01 PM

#55842 RE: BonelessCat #55841

Thanks, that was my thought as well. I like that Leo is aggressive but that seemed like a stretch to me.
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DoubleJ23

03/06/14 4:12 PM

#55844 RE: BonelessCat #55841

BK, the reason I was questioning this a few weeks ago was because there were at least two other companies(I don't remember them now) that applied for Fast Track status for OM drugs. I wondered why the other companies didn't file for orphan status and just went with FT. Maybe Leo and Menon think even though it is a "long shot", the fallback is Fast Track, so why not take a chance.

I think what CTIX has going for them is the pre-clinicals were SO effective that the FDA will want to push this through, though I wonder if maybe the FDA can grant some of the benefits of orphan status without, say, the 7 year exclusive marketing benefit and maybe drop another one of the benefits.
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noretreat

03/07/14 8:56 AM

#55862 RE: BonelessCat #55841

Here is the third recent thing we agree on. I was very surprised when they applied for OD status because the condition is far from orphan...both is terms of frequency and in terms of the number of companies developing treatments. Orphan Drug designation was for rare diseases not being addressed by the market.

I will be very surprised if they get it ... pleasantly surprised.