There are probably lengthy discussions with the FDA about how best to be effective with LL, like dosage, severity timing, delivery (remember LL can be out patient doctors office or even home injections) and then the distribution, manufacturing, storage, etc. I was only joking about speculation in my last post because the speculation that is going on in the last few posts today is very informative and very positive and makes me certain at this point that there is NO need for discussion with the FDA if the results were negative.