My only quibble would be that the numbers for screening will be...

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15/03/18

16:13

Post #: 31782751
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Originally posted by CroMagnon ↑

It is amazing - to me at least - that every post is so upbeat.

There are, at least, two items that should cause grave concern:
1) Page 14 - Recruitment status: 110 (or so) randomised vs. 190 (or so) screened at end of Feb 2018 -> that's an acceptance rate of 110/190 = 57.9%. For the indicated end-of recruitment of June 2018 (that's 4 month remaining) 168 - 110 = 58 patients needed for randomisation. Using the current acceptance rate there would be a requirement for at least 100 patients in screening (58 / 0.579 = 100.17) . The corresponding monthly randomisation figure would have to reach an average of 25/26 ( = 100 / 4 ) patients. I can't see that happen and I am sure I am not alone with that.
2) Page 6 - "We have collaborated with Paraxel to manage the cost impact, agreeing: .........."
What precisely is the meaning of 'significant discount' ????
Is there a new 'Recruitment deadline' ??? Because it is highly unlikely that randomisation will reach its target of 168 at the end of June 2018.

I do apologize in advance if I am wrong with the above.
It is hard to be upbeat when the time frame is ever shifting - another three month's here and another don't-know-yet month's there. And then there is the weather and (possibly) D.J. Trump twittering about his views on medical research outside the United States .
The possibilities for delays seem to be endless in FTT's case.

Not to forget the comment from Supertramp:
"Alchemia did a large trial for their cancer drug (over 200 subjects). The drug did well, but the placebo did the same. So they failed the trial and collapsed! There were questions asked as to how the placebo group did so well."
A possible answer is (relating to FTT): One can safely assume that standard-of-care has improved a lot since the early 2000's (and that was the time frame for the comparison study everybody refers to). My guess is a 15-18% improvement for VF00102 when compared to standard-of-care.

Supertramp: There never ever was another clinical trial and that's why you couldn't find the data.

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My only quibble would be that the numbers for screening will be lower than you suggest given improvements in recruitment to the 2 weeks screening. They were suggesting about a 20% elimination after screening now that the centres are into the swing of things. That would mean having to recruit another ~80 patients to get the remaining 61 for randomisation. Will it be June or July? Does it really matter in the scheme of things?

FTT Price at posting: 4.3¢ Sentiment: Hold Disclosure: Held
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My only quibble would be that the numbers for screening will be...

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