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26/06/20

20:48

Post #: 45481841
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Originally posted by camviv: ↑

I am no lawyer but these stand out for me

This is the main thing "Safety" - will anyone be injured or die from taking this drug,
(1)End-of-Phase 2 meetings--(i)Purpose.The purpose of an end-of-phase 2 meeting is to determine the safety of proceeding to Phase 3, to evaluate the Phase 3 plan and protocols and the adequacy of current studies and plans to assess pediatric safety and effectiveness,

also BOT have had to provide their plans moving forward 1 month in advance of the meeting
(iv)Advance information.At least 1 month in advance of an end-of-Phase 2 meeting, the sponsor should submit background information on the sponsor's plan for Phase 3, including summaries of the Phase 1 and 2 investigations, the specific protocols for Phase 3 clinical studies,

The FDA call the shots of when
The meeting will be scheduled by FDA at a time convenient to both FDA and the sponsor. Both the sponsor and FDA may bring consultants to the meeting. The meeting should be directed primarily at establishing agreement between FDA and the sponsor of the overall plan for Phase 3 and the objectives and design of particular studies.

The FDA can give its best judgment at the time of the meeting or defer it
FDA will also provide its best judgment, at that time, of the pediatric studies that will be required for the drug product and whether their submission will be deferred until after approval.

Expand

so the company has already shared protocols and plans with FDA which includes the size and scope of the planned Phase 3 studies, let’s hope they provide shareholders a slide deck update with the same information.

BOT Price at posting: 3.9¢ Sentiment: None Disclosure: Held
2 Upvote

0 Great analysis

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