Dew, as someone familiar with mathematics, you should know that the actual numbers and length of time that patients and volunteers have been subjected to ATryn might be considered significant to the discussion. Any other type of statement is just a subjective feel good post.
Do you have actual numbers for your statement? How many have been subjected to Atryn and probably even more important, for how long? It might take time to develop a immune response. Aren’t many of the drugs GTC proposes to get approved intended to be used by patients for long period of time?
Thus my comment about actual use of ATryn in patients after approval. If ATryn had been used in more than some nominal number of patients that would increase the safety profile. It might be that no patients have received Atryn after approval?
I don't know if there have been any sales of ATryn, has there? Because at least if there has been sales that is some form of data that will reassure the FDA.
Perhaps the FDA has something that they require companies to do to test such drugs produced in a novel means in a wider trial for a longer time with protocols and procedures to measure results? This would probably require some time to develop the data.
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