The other board hadn't picked up on the letter yet
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Posted On: 07/24/2018 3:55:19 PM
Re: freedomdreamer #13564
The other board hadn't picked up on the letter yet, I told them about it. I've previously stated that I thought the company was headed in the direction they've taken, I just don't know how far they'll take it.
It's clear in the letter that they want to demonstrate efficacy before anything is put on the market, the question in my mind is still, to what degree.
If they wished, and an IRB agreed, they could do unblinded Phase 2 trials that were intended to demonstrate efficacy from the first patient with a condition entering the trial. In that circumstance, after a small number of patients, perhaps 20 or less, if all were seeing substantial benefits, the company could show the benefits and market the product. That's one extreme. The other, and far more likely is running a traditional Phase 2 which is blinded, will take longer, and results won't be reported until the trial concludes.
Still the question would be, if the Phase 2 trial clearly shows efficacy, do they go to market, or do they go into a larger, longer, and more expensive Phase 3 and take the product completely to approval before it's ever put on the market.
Regardless of what approach they take, the company can still be very successful, and the stock price can rise dramatically, but we need to see that products are truly working well, until that's seen, or they bring in a major partner to work with them, I don't believe we'll see large gains. Remember GWPH didn't have product approval when they reached multi-billion dollar market caps, but they did have trials that supported the likelihood that they would gain approval over time.
Gary
It's clear in the letter that they want to demonstrate efficacy before anything is put on the market, the question in my mind is still, to what degree.
If they wished, and an IRB agreed, they could do unblinded Phase 2 trials that were intended to demonstrate efficacy from the first patient with a condition entering the trial. In that circumstance, after a small number of patients, perhaps 20 or less, if all were seeing substantial benefits, the company could show the benefits and market the product. That's one extreme. The other, and far more likely is running a traditional Phase 2 which is blinded, will take longer, and results won't be reported until the trial concludes.
Still the question would be, if the Phase 2 trial clearly shows efficacy, do they go to market, or do they go into a larger, longer, and more expensive Phase 3 and take the product completely to approval before it's ever put on the market.
Regardless of what approach they take, the company can still be very successful, and the stock price can rise dramatically, but we need to see that products are truly working well, until that's seen, or they bring in a major partner to work with them, I don't believe we'll see large gains. Remember GWPH didn't have product approval when they reached multi-billion dollar market caps, but they did have trials that supported the likelihood that they would gain approval over time.
Gary
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