Having worked in the Pharma Industry it is only logical/ideal that a partnership would be reached prior to NDA submission. P3 results met primary endpoints and secondary benefits improve the market story vs. current 'fast-acting' insulins. (i.e. Fast just got faster, plus reduced hypo, at least weight neutral etc.) Partners don't need anymore information. My assumption would be the partnership details would include milestones, including approval. For this to be a success, MNKD and the partner need pre-launch time to talk about the challenges with current fast acting insulins, hypo rates etc. This requires many months of work, not to mention the time to finalize strategy, marketing materials, and prepare for training the sales force. They would also need time to manufacture initial product batches to fill the distribution channels.This would all occur during the review by the FDA, so they are ready if they receive an approval in 2014.
Sentiment: Strong Buy
You are correct. I feel we will see a partner before the end of the year. Why? Ramp up manufacturing, physician education, understand the nuance of selling in the diabetic community, sales representative education and I'm sure there are many more. As far as I am concerned the sooner the better! Mannkind needs a partner ready to hit the road running upon approval!
Sentiment: Strong Buy
it sounds to be very logical to expect a lot of time for the partnering process. what i don't see is the reason why the partnership would be reached before NDA submission. could you elaborate?
YA--many of us have noted this in past postings and it remains very viable and HAS TO HAPPEN. That is why Greenhill's mission is to bring the bacon home, the DD is done, the latest data is digested and now it's time to pony up at the bank bar. I don't think the FDA will take six months for review--fast track it---so time is running out to respond as you have suggested above. If fast tracked, look at 3 months to approval = Dec-Jan which is right around the corner; the clock it ticking and time is $. See that light at the end of the tunnel? OH, it's not a train this time.
JMO. Pharma companies want to time everything to coincide as close as possible with potential approval. Obviously, they need to weigh the risks, but they are often willing to produce limited amounts of product at risk in anticipation of the approval. This depends on their level of confidence in the data. If they get an approval then they can go to market immediately. If they don't do all of the above then each month that passes is revenue lost and time for other competitors to continue with their defensive strategies. So, signing a partner before submission to give 6-7 months of prep time is ideal.