Doc Logic, these types of studies tend to get more value from each case because the science has advanced so much and there is so much being learned. But, I think you are getting into an area where you are walking such a tightrope. As you know the data will be parsed deeply in all dimensions, but, this is still one trial. Maybe I am thinking old school here but it is important to keep your eye on the big ball and not try to do too much and wind up with too little. They certainly could have implemented the next generation of automation when they set up mfg shop in Germany and they could have implemented the use of TFF at the same time, assuming they had done all the pilot development work at Cognate and they knew they would not negatively affect the quality of the product. Even when making product improvements it is a very thin line during clinicals. It is typically best to wait and submit for changes post approval than to make the changes during the trial because of the chances for complications resulting. It is rarely worthwhile to mix the two, trial execution and process improvement, unless, there is overriding reasons to do so and clear agreement on the pathway and excellent pilot work to prove the change prior to implementation. Lastly, it is typically much more difficult to manage a product improvement than to manage an efficiency improvement, which may be the main reason they may have implemented TFF. They may have been able to prove using TFF improved the efficiency of filtration but did not change the end product, which is easier than to prove you have improved the product and thereby now have almost a new study underway. There is a complex line here. If Germany was a point of process automation (which typically is an efficiency improvement and a GMP improvement, basically automating the current process) and if Germany was a point of implementing TFF it is my guess it was all for process efficiency, which can mean increased capacity, improved GMP's and improved COGS, but, not for product improvement. That all being said it is not impossible to improve the product in a very controlled space and in a very controlled way, but, it is difficult and not what I think they are doing. I think the issue here is all about deepening the understanding of the patient characterization to develop the therapy application and to interpret the study results, hopefully with sufficient benefit across the entire body of patients. Again, this tends to be an area where BP's have the resources to perform more supporting studies which tends to help in identifying patient populations,... prior to expensive P3's. I think and hope they are learning a boatload and the gross results will be sufficiently robust that their knowledge gained will propel them ahead at the lead of the pack here. I think they are not performing product improvement but probably some process efficiency improvement, which mfg entities will brag about. This science and technology is so broad but yet so deep it is everything fascinating and hopefully even moreso patient beneficial asap.
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