I FOUND THIS TRANSCRIPT FROM MAY 4, 2017 - Where they happened to mention a little more info about Fiasp, and the coming FDA approval in the U.S. --- So far, i had only been able to find an article which mentioned that NOVO was preparing to send the additional information that the FDA requested to complete the approval process, and it would be submitted by May 5, 2017. -- But looks like GOOD NEWS! things seem to be moving along a little bit faster than expected...... Pulled this quote from a transcript with Novo Nordisk Officials discussing Finances and projections, but they happened to mention Fiasp (just once) but the information is revealing and seemingly good news.
*e _**have end of March resubmitted the drug application for Fiasp, fast-acting insulin aspart, and we remain assured that we have cleared the challenges raised in the complete response letter from the FDA, and that hopefully should lead to a 6 month review time and hence approval by the end of third quarter in the U.S" **
So, i believe that ive read somewhere that in a similar situation (resubmittal of a Complete Response Letter + supplementary info to complete the FDA approval) (for another insulin product, not sure which?)- they recieved approval in only 4-5 months. ----- Therefore, if Fiasp was resubmitted on March 31, April 1st.--- Im hoping we will see approval sometime in August, or Early September. ///
Set your calenders all! - Im really excited about this because, i feel, that the largest barrier to successful hybird closed loop operating is the delay, lag-time, of insulin absorption,.....Fiasp doesnt seem to be perfect, but should be a significant step forward in reducing both the severity and the duration of postprandial spikes, leading to more time "in range", and the ability to respond to unexpected rises, giving correction doses more quickly and again ....resulting in more time in range. Fiasp has a quicker & stronger initial effect, so the tail is much less potent that it has was with Humalog, Aspart, and Novolog. This means stacking wont be as large a problem, and should result in fewer unexpected lows, and any lows should happen slower, and be less severe (assuming you've correctly matched your prandial spike, with your insulin effect spike) ...
Id love to see some more data on Fiasp & its pharmacodynamics & and actual user data, especially anyone who has been pumping using it. If anyone has any info - please let me know- email me: email@example.com and/or post it on here- and i will try to post all i can find, in an organized way onto my website. (which ive been putting off building, but im Actually gonna build and get it "up" this weekend sometime. details to follow.
+_P.S. - im looking to get my old Paradigm 723 pump repaired, or get a pump donated, maybe 2.. to use as project pumps to start Looping. _
There is a 13 y.o kid at my Endo's office, whos insurance isnt covering a pump for at least 18months and only if his A1C IS ABOVE 10 or something crazy like that.... His parents have become good friends of mine, they're just super good, hardworking ppl - but just cant afford a pump outright, so id like to be able to build him a setup too... he really wants a pump and is interested in the whole hybrid closed loop system, so id like to build one with him, let him learn how to do a little programming and adjust his levels, etc... then suprise him by giving it to him when were done.
Im developing some really cool predictive algorithms, that are wayyy more advanced than the ones ive seen around. Long way to go, but i thinks its gonna be really intuitive, unique, personalized, and just plain awesomeee!!!
So, if anyone has a line on how/where to get some of these things relatively inexpensively, or an old one donated from someone who doesnt need it anymore or who has a spare. please let me know. Thanks so much. + i could always use some help/advice/ from anyone with looping experience. se vous pleiz! Thanks. Be well ....