Again you are misunderstanding where i am coming from
Our 1103 study was not done on a per mg to KG ratio
it to was done on a standard dosing per wk but once the results had come through the wringer they deducted that results could basically be calculated as to their, being the drugs use, could see that the larger weights were not showing the same results as the lighter weights
therefore they deduced in their calculations that the dosing per outcome of drug effect could well be worked back into dosing per MG against Kg for maximum benefit to each and every individual with a calculated clinical benefit
So for instance in our trials as we have already seen different results across the board from our Ph2 trial recently conducted
The differentiate between these boys could be down to Body weight ie MASS to DOSE
NOTE from 1103 study
In the 4 patients who received the 400 mg per week dose, ATL1103 reduced sIGF-I levels consistently and by an average (mean) of 30% (range 4% to 48%) at week 14 (one week past the last dose) which is the primary efficacy time point for the trial. sIGF-I levels were reduced by a mean of 38% (28 – 48%) in the 3 patients who had lower body weights (58 - 83 kg at screening) and thereby received a relatively higher dose per kg bodyweight. The one patient showing the lowest sIGF-1 reduction at week 14 had the highest body weight (132 kg at screening).
Now once more data is generated it could be deduced that better results are coming from the lighter boys
It could also be deduced that the greater the numbers of CD49d in the boys could also show greater improvement in some than others ie CD49d PREVELANCE
This is why i stated in previous posts, if we do include Ambulant boys, the the boys that are ambulant would have to be screened for present stage of CD49d in the system, and hence i inferred this trial could be a lot more comprehensive than our EU
But i am fine with this, If they are going to do this then lets cover all possibilities,
Much like George has stated we have already complete one 6 month study, yet it could turn out we may have to do a follow up 9 month study, ( worse case scenario )
I for one would not like to do a 12month study in none ambulant children, find we have traffic results once more, but have to exclude ambulant boys with elevated numbers of CD49d because we have no data from Ambulant boys
We have to cover all the bases taking this forwards not only for the benefit of these children with the disease, but also for our benefit as shareholders to extract maximum value for investments
Yet because i post in this way i am considered a pessimist, a down-ramper or whatever
You dont have to reassert my narrative it is as i have written i regret nothing and its there for you or anyone for that matter to contest
i am realistic look at your comments on the one meeting is good enough yet clearly that is not the case
We will go forwards with this drug of that i am sure but as yet there is still a lot of water to go under the bridge so to speak
anyway enough from me
SEE HOW WE GO
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- Ann: US FDA Type C Meeting for ATL1102 in DMD
Ann: US FDA Type C Meeting for ATL1102 in DMD, page-68
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