The health regulator sought certain additional data to satisfy requirements pertaining to chemistry, manufacturing, and controls before the treatment, called pz-cel, can be approved, in its so-called "complete response letter". The drug developer is seeking approval for the treatment in patients with recessive dystrophic epidermolysis bullosa, where the skin becomes fragile and blisters can appear through rubbing or exposure to heat. FDA in its response letter indicated that the proposed timing of the data submission would not allow sufficient time to complete its review by May 25, the set deadline to decide on the application.
take a look at the video that the syrian state tv put out, there are no signs of those victims having muscle spasms. there is no skin blistering. those are the kind of symptoms you would see. if what are called schedule one chemical weapons under the chemical weapons convention had been used. those include saran, mustard gas. it doesn t mean that a schedule 3 chemical substance might have been used that would include something like chlorine that could cause the kind of breathing difficulties that some witnesses said they witness the witnessed or felt but in coo in some circumstances cause death. shepard: jonathan hunt, thank you. colorado will soon allow gay couples to have civil unions several years after the state banned gay marriage. hickenlooper signed the bill into law. it takes effect into n. two months. colorado will be the sixth state to allow same sex unions.