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.