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Tuesday, March 15, 2022 5:44:30 PM
That doesn’t follow, if anyone reads the full post. That is clearly just reasonable speculation. That some people don’t like that his or her post is quite reasonable and inconsistent with their own narratives is just the breaks.
Plus the post said it could happen even tomorrow. I think he only meant that approval and scale-up of Flaskworks or maybe just approval of Flaskworks as the new manufacturing method.
Personally, I do not believe they need to have Flaskworks fully approved for approval, I do think they are likely far along on that effort though and that the regs are not as difficult or worrisome as some suggest. In fact another company I am in, just got their new bioreactor manufacturing approved by FDA in the middle of a trial, and they do not yet have a fully functional factory yet. Updating manufacturing during the trial and/or pre-approval or as a company is moving toward approval is expected and they’ve tried to make it less difficult and burdensome by updating their regs. Plus the MHRA seems a bit ahead of the FDA on many of the reforms FDA is working toward now. We’ll see, but again, all just IMHO, I think they are working hard to address all the challenges based on results that from the interim look likely to be very, very exciting on revelation of TLD, but validation still requires that they go through certain hoops, some still being defined. These things, IMHO, seem to me to suggest that the concurrency of certain events would be advantageous.
Plus the post said it could happen even tomorrow. I think he only meant that approval and scale-up of Flaskworks or maybe just approval of Flaskworks as the new manufacturing method.
Personally, I do not believe they need to have Flaskworks fully approved for approval, I do think they are likely far along on that effort though and that the regs are not as difficult or worrisome as some suggest. In fact another company I am in, just got their new bioreactor manufacturing approved by FDA in the middle of a trial, and they do not yet have a fully functional factory yet. Updating manufacturing during the trial and/or pre-approval or as a company is moving toward approval is expected and they’ve tried to make it less difficult and burdensome by updating their regs. Plus the MHRA seems a bit ahead of the FDA on many of the reforms FDA is working toward now. We’ll see, but again, all just IMHO, I think they are working hard to address all the challenges based on results that from the interim look likely to be very, very exciting on revelation of TLD, but validation still requires that they go through certain hoops, some still being defined. These things, IMHO, seem to me to suggest that the concurrency of certain events would be advantageous.
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