IMO Trding , If they approve very soon IND for col
Post# of 154003
(Total Views: 361)
Posted On: 05/30/2019 12:00:43 PM
IMO Trding , If they approve very soon IND for colon cancer , yes they will need phase 1/2 since TNBC is not event started , If it will be later , who knows how FDA will decide ...
It is very hard to predict , I spoke once with Dr NP , and I said something like , by now FDA know how safe our medicine is , and he answered me something like ,
yes they know , but they still saying , it is safe in few hundreds but we will see with many thousands or hundred thousand patients ...
But I am sure that by know, whatever they are saying , they feel much more comfortable with safety here,
Not long time ago I posted here little about history of Thalidomide we all study about in medical school , they study about it until now ,
Because it was a long time ago since my medical school...
)
I read again now on the computer ...
It is very interesting and very tragic story ..
It was first developed in Germany in 1950s , after very successful studies with mice it was approved for humans ...
And since it showed no problems and calming effect very often , it was put over the counter , with advice as mild sleeping pills , safe also during pregnancy.
And we know what happened ....
" Thalidomide disaster is
one of the darkest episode in pharmaceutical research history "
After all tragic things happened to patients with it , worldwide approval for medicine started , and everyone took it seriously.
I will advice everyone to read this story about Thalidomide , after I read again , I developed more patience to our FDA ,
they really have very difficult work to do.
It is very hard to predict , I spoke once with Dr NP , and I said something like , by now FDA know how safe our medicine is , and he answered me something like ,
yes they know , but they still saying , it is safe in few hundreds but we will see with many thousands or hundred thousand patients ...
But I am sure that by know, whatever they are saying , they feel much more comfortable with safety here,
Not long time ago I posted here little about history of Thalidomide we all study about in medical school , they study about it until now ,
Because it was a long time ago since my medical school...
) I read again now on the computer ...
It is very interesting and very tragic story ..
It was first developed in Germany in 1950s , after very successful studies with mice it was approved for humans ...
And since it showed no problems and calming effect very often , it was put over the counter , with advice as mild sleeping pills , safe also during pregnancy.
And we know what happened ....
" Thalidomide disaster is
one of the darkest episode in pharmaceutical research history "
After all tragic things happened to patients with it , worldwide approval for medicine started , and everyone took it seriously.
I will advice everyone to read this story about Thalidomide , after I read again , I developed more patience to our FDA ,
they really have very difficult work to do.
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