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docbanker

02/25/08 5:25 PM

#3441 RE: DewDiligence #3440

I'm glad you showed up finally after all your doom and gloom pre-IND effective postings.
i) they got the dosing they want
ii) they got the timeframe they want
iii) the bar is 1/2 what was seen in prior studies (where the effect was retroactively studied)
iv) similar patient number as seen with prior studies

FDA seems on board to me.
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corpstrat

02/25/08 5:37 PM

#3442 RE: DewDiligence #3440

<<I did not specify probabilities that the IND would be accepted >>

Quite so. You merely warned us not to take it for granted, thereby putting the wind up several posters here.

Now how about giving us your WAG of probability that the anemia trials will succeed. If you can do one for the UF and / or endo indications based on info to date, that would be still better.

If your probabilities come in above 10%, you might consider taking a flutter on RPRX!
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y3maxx

02/25/08 6:01 PM

#3445 RE: DewDiligence #3440

Dew,,,interesting.

Of all the posters & posts,,, you pick me/mine to defend your position regarding RPRX.

,,,Looks like RPRX stands a little better chance than you are willing to admit.

I may be a medical neophyte but i can read between the lines about people.

,,,All we need now is ThomasS singling & critiquing me then we will all know they are both accumulating shares,,,

good luck





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io_io

02/25/08 6:06 PM

#3446 RE: DewDiligence #3440

<"there was not a single post discussing the anemia trial design until RockRat finally chimed in.">


Well it was a stupid board here Dew until RockRat helped us out.

Either that or we noticed that the "design" (I presume you mean the arms' size, as the dosing durations etc have certainly been discussed) is nearly identical to the UF trial, discussed already ad-nauseam .....
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Nerf

02/26/08 6:26 AM

#3450 RE: DewDiligence #3440

<Actually, I did not specify probabilities that the IND would be accepted or rejected>

Actually, you just said the fact that they wanted a new IND was scary. So, I would place a pretty high value on the probability NON ACCEPTANCE in just that term alone. Scary, means that fear is involved and the only thing that would really HURT is if the FDA said "no". That would be the only scary scenario.

What's really comical is that you mentioned "trial design" in your first post acceptance comment on the matter, yet there hasn't been any follow up comments. Was that just because you thought it better just to leave it at a vague "trial design" comment and see what trouble that would stir up? FUD without the FUD?