you are right. biod 123 is absorbed faster but it didn't control hba1c levels better than Humalog. the whole point of a faster acting insulin is to control hba1c better, which biod 123 does not. so while it may be faster, it is not any more effective.
Let me try and respond to your point as follows: Let's assume you have two type 1 diabetics with the same A1C levels (say 6.0), remembering that A1C is an average glucose level for the past 60-90 days. One of them has a constant reading of glucose levels (say 100-110) daily and averages over the 60-90 days at 108, but the other has daily readings between 50-200, but averages out at 108 over the same 60-90 day period. They both have the same A1C, but one has much less damage done to their eyes, kidneys and hear than the other due to the narrower range of highs and lows in blood glucose levels daily.
Been in the industry 25+ years. There is no chance BIOD shelves 123 at this point. Not unless they want a drawer full of lawsuits and permanent loss of industry reputation for all all involved.
The highest hurdle has been jumped, and the drug never would have gotten to phase 2 based on your assessment of FDA process.
No improvement over Humalog? Weird statement on about three different fronts, starting with the fact that BIOD-123 is not in the same class of therapy as Humalog. It is next generation, ultra fast acting.
Sentiment: Strong Buy
This is becoming SO tiresome...
The FACTS are:
1. It is an improvement over Huamalog by definition, because it's a FAST-ACTING insulin.
2. The demonstrated non-inferiority, proven with P2, pertains to CHANGE FROM BASELINE HbA1c.
3. One of the proposed targets for the new product (lower admnistration site pain) was compromised by (minimal) higher incidence.
Get your ducks in a row, once and for all.
That demonstrates your poor understanding of the FDA.
The FDA's decision on whether or not to allow a new drug come to market is not based on superiority.
If this was the case then there would be no aphidra on the market since humalog already existed.
Non-inferiority and safety are the key steps. FDA will let the market decide whether or not the drug will be successful.
The secondary endpoints are key.
I'd like to see the CGM data on decreased postprandial glucose excursion as well as the real breakdown of hypoglycemic events.
These will be good endpoints to meet...they will make BIOD 123 a marketable and SUCESSFUL new insulin.
paul, really, before you start posting you should read the report and the data vs. humalog. Saying there is no improvement is a lie. A flat out lie. So you either are paid to post, lost money on BIOD and are frustrated, own a competitor and are afraid of BIOD's superiority, or some other motive for not being truthful in your post, I'm sure you have no position in BIOD. WHAT IF eliminates any REAL meaning from the rest of your post.
big difference between the two,remember biod 123 is a rapid acting insulin,while humalog is not,kinda like apples,and oranges. if you don't get it,hey what can one say,i will say this,there's one big bargain in danbury connecticut though !!!!!!