This needs addressed ASAP by Mannkind. This was afterall, a trial to compare Dreamboat to Medtone, per the FDA request. All this is doing is providing ammo for the shorts to hit us hard.
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Mannkind slips on cautious note out of Summer Street • 10:44 AM
- Mannkind ( target="_blank">negative note out of Summer Street this morning.
- The firm appears to be suspicious of the results of the drug developer's Phase III AFFINITY 1 trial, after they released results on the injectable insulin and Dreamboat arms but withheld the results on the Medtone C-arm.
- Releasing data on only two of the three arms of the trial like that is unprecedented.
- If the results on the Medtone C-arm aren't worthy of presenting and inhalers aren't equivalent, then Summer Street feels there's not enough safety information to approve Dreamboat.
