Ann: FDA Strategy and Regulatory Update, page-118

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14 Posts.

09/08/20

09:13

Post #: 46404101
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Originally posted by Kotlass: ↑

IMO, Day 60 it is. Note the use of the phrase "substantive interaction" by the FDA and "substantial equivalence" in the ANN. I reckon it is a process where the FDA conducts a substantive review of the applicant's submission (or product) by comparing it to an existing FDA approved device (...refered to as "chosen predicate device as per ANN). In other words, what is the intended use of MEBsleep and how does it compare to the "chosen predicate device"? A satisfactory response is required before the application/submission is accepted for "Interactive Review". Apparently, the Interactive review is the final review preceeding an MDUFA decision.

However, MEBsleep is yet to be accepted for the Interactive review as per the ANN ("Upon FDA's satisfaction of Medibio's response, MEBsleep will be officially accepted for review"). When this milestone is reached, it's a 30-day count to FDA sending final MDUFA Decision on MEBSleep. Please note that a decision may not be reached if there are still issues by Day 90 following which the FDA provides a communication that identifies outstanding issues by Day 100. Let me add on behalf of the FDA that the timelines/duration stated should only serve as a guide.........applications are assessed based on individual circumstances (if you have ever applied for a visa you should be able to relate to this).

MEBsleep is the first component of MEB001 and has commercial value in its own right. For this reason, the company is seeking to expolit the commercial value in parallel once FDA clearance is received and CE application approved. The FDA approval process for the MEB001 is expected to take 6-9 months maybe longer due to Covid and the fact that MEBsleep clearance is still pending at Day 100. It wouldn't matter much though if MEBsleep clearance is received. The potential to earn revenue is activated before conclusion of MEB001 trials.

This is my understanding of the ANN. Maybe seek clarification from the company directly if in doubt?

Sentiments: The profit here is not for the impatient and that includes not just traders but those suggesting a clearance next week. If we are to accept management's view that the FDA clearence will eventuate, it's a buy (or hold) and wait. IMO, not an investment advice please.

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hey Kotlass, wondering if its day 60, when does that leave us? which day do you reckon the approval is reasonably granted?

MEB Price at posting: 1.2¢ Sentiment: Hold Disclosure: Held
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Ann: FDA Strategy and Regulatory Update, page-118

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