What Danger You Ask?
Danger #1, the FDA doesn’t like the data, and you own the stock.
Danger #2, the FDA does like the data, and you don’t own the stock.
The way we look at it, we have one hell of entertaining month ahead. Inflation doesn’t matter. Jerome Powell and interest rates doesn’t matter. Twitter suing Elon, doesn’t matter…
The only FED that matters to us is the Federal Drug Administration’s (FDA) view of Revive’s data – as it relates to Bucillamine and how helps or doesn’t help COVID patients.
THIS IS WHAT WE KNOW
On June 16th, the Company said it “..submitted a Data Access Plan to the FDA with the aim to unblind the pre-dose selection data.”
Then they stated, “..the Data Safety and Monitoring Board (“DSMB”) are scheduled to meet thereafter to evaluate the interim clinical and safety data and may make a recommendation on continuing the Study or advise on halting the Study early due to positive efficacy.
On June 24th, the Company said, “..receiving positive comments from the FDA in regards to the Company’s request to determine and agree on the Study’s potential new primary efficacy endpoints and the Company’s submission of a Data Access Plan (“DAP”) to the FDA, the FDA has accepted the DAP to allow for the unblinding of the pre-dose selection data.
So, don’t say we didn’t tell you. Don’t say “I didn’t know.”
As usual we make zero prediction as to the FDA looking at the data favorably, so-so-ably or un-favorably. Zero.
The risk to reward is a little less than when we added it to the Watch List at $0.22. But still very, very favorable.
Revive Therapeutics: Our Best Risk to Reward Idea Ever?
Here’s a news archive, if you haven’t been paying attention or need to re-review. News Archive.
As a side note, we once had favorable ‘but with conditions’ review from the FDA before and we got pretty banged up ($13 to $4.00). The FDA said the commercial product differed from the trial product – wait, what? Approved but not? Ouch.
But wait, there is a stock market God and they just raised $60 million so we are once again adding it the Watch List. Rumors are good news by November from ‘our people.’
Revive is a client, please see report disclaimer and disclosure details. And we’d like to have Provention as a client.