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Post by Deleted on Aug 2, 2014 10:17:59 GMT -5
The insulin market being as big as it is, can we expect any interference from the DOJ or FTC to any marketing or takeover deals?
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Post by mannmade on Aug 2, 2014 11:19:37 GMT -5
It's not the size of the market that counts so much as it is the number of players and how it effects the consumers access to products/protocols. I think there are sufficient number of players in this field so should not be too deep beyond normal scrutiny.
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Post by hammer on Aug 2, 2014 13:00:00 GMT -5
The insulin market being as big as it is, can we expect any interference from the DOJ or FTC to any marketing or takeover deals? This is very interesting speculation. I'm not a conspiracy theorist, well maybe just a bit. I firmly believe that some politics were played with MNKD's struggle for approval. Good luck proving that conspiracy though. I bring up 2 points that may back up your thoughts. I cant remember the specific date but Al Mann attended a conference in which the ADA and notably Margaret Hamburg was presenting, prior to the second CRL. During the course of the meeting Al Mann stood up to point out the cost of bringing innovative drugs to market could easily cost several billions of dollars and due to excessive risk adverse federal regulations could easily provide an environment in which innovators leave the US to seek approval in other markets first.
This was a cannon ball "shot across the bow" to the FDA and a very valid point. Much like national defense security, the national economic security in this nation is extremely important! Just as ADCOM was a public vetting of Afrezza, Al's point at the conference was about as public as you could go to Margaret Hamburg. Shortly after this encounter I believe Al was invited by the Chinese government to give a speech to their academy of physicians. Imagine an innovative product like Afrerzza which has the potential to be a lead product in its market, homegrown and developed just to be sold by economic interest to a competitor nation. Yes, you could bet the FTC or another agency would step in and squash the sale.
As an example look at the sale of 3COM to the Chinese company Hawaei. Since 3COM provided much of the infrastructure to the US defense Dept, this sale was scrutinized and allowed to advance with caveat. What would be the effect on the US Pharma industry if competing countries were more endearing, cheaper, less regulatory. I am a believer in lead, follow or get out of the way. On to the second point. As of late, we are witnessing that many US companies across a broad range of sectors are looking to partner with companies across the pond in order to decrease tax liabilities. Governments response to this is in no manner assistive. Governments reaction of late is wither and die because they plain will not allow it, by executive action alone. The tact they should be using is what can government do to help these businesses rather than retard their growth. That's politics so I wont go any further.
Do I agree with your assumption? Yes I do, but we will just have to wait it out to find out.
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Post by babaoriley on Aug 2, 2014 15:50:58 GMT -5
The insulin market being as big as it is, can we expect any interference from the DOJ or FTC to any marketing or takeover deals? Would be very surprised if either reared its ugly head on Afrezza's horizon. |
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Post by mnholdem on Aug 3, 2014 9:42:39 GMT -5
I think the agencies will limit their scrutiny to a simple determination of whether any Agreement is in violation of SEC regulations,IMHO.
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Post by ezrasfund on Aug 3, 2014 21:58:04 GMT -5
Hammer, Al's comments about the risk averse FDA, which you recall correctly, were made at the Milken Institute's 2010 "Partnering for Cures" conference. Hamburg was on the stage with Janet Woodcock, who responded to Al's comments.
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