Not heartbeat, more like heart attack when FDA shoots this submission down
Again, the Phase 2b submission doesn't stand a chance.
A Phase 1 submission has better than even odds of approval. Assuming certain changes were made.
So why didn't Kenny go with a Phase 1? Because his pump is a Phase 2b will be approved, after 6 months victory, and it goes flying through Phase 3 into the market in a year. Whereas with Phase 1, it's 6 months-1 yr, followed by 2-4 yrs for Phase 2, and another 2-4 yrs for Phase 3.
But that's not the problem. Even before Covid "pay as you go" for funding a CT was nonsense. Now even more nonsensical.
Then there's the problem of obtaining full enrollment for a PC clinical trial. CTs in late stage testing, with very good prior earlier trial data are taking 6-12 months to obtain full enrollment. Along comes Kenny... convincing SHs, patients are going to flock into a CT featuring the Kenny Wonder Treatment with no prior clinical data to back it up. There will be no quicky CT. Not happening. Likely would take years to obtain full enrollment.
Who knows what the PPS might do as a result of irrational retail reaction. But GL in trying to keep 1.5B shares up. The 3rd parties aren't paying $15K/month for PR pumps, so that retail can gain profit. They are paying the $15K/month so that they can dump into any irrational retail buying.
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