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@BiotechCH ".@MatteisPaul adds to the conversation on the FDA: Were still trying to figure out who this FDA is and there have been a lot of paradoxes so far. On the one hand Makary's commentary on biological plausibility sounded like Peter Marks XXX from the perspective of flexibility and industry friendliness for a gene therapy. Weve seen a lot of companies in this rare space continue to get these regulatory agreements that look very very favorable.On the other hand you have this whole piece with Prasad and all the past commentary he's had. #BiotechHangout"
@BiotechCH on X 2025-07-25 16:43:43 UTC 14.6K followers, XXX engagements

"As CEO I felt that it was doing something. I didn't think it was a cure or the best technology that was ever produced but we thought it deserved to be approved. I think that transparency is the issue and I think that's what @adamfeuerstein hit on shares @cngarabedian on the scrutiny biotech leaders can face. That credibility is a really important part for buy siders to invest and trust the story that they're being told by a management team. #BiotechHangout"
@BiotechCH on X 2025-07-18 16:39:58 UTC 14.6K followers, XXX engagements

"How are FDA decisions on $REPL affecting investors @EricSchmidt151 says Anything that was agreed on in the past needs to be re-agreed upon under the new administration and FDA leadership. Theres going to be a risk of surprises going forward. We all know that investors hate that so when it comes down to increased uncertainty in our industry that means increased cost of capital and that means something that's not directionally where we want to be for stock price movements. #BiotechHangout"
@BiotechCH on X 2025-07-25 16:53:18 UTC 14.6K followers, 1951 engagements

".@SamFazeli8 adds that I would have approved the drug and let physicians decide how to use it. Its possible that the FDA can say that the standard of care has changed and $REPL should have a control arm. The FDA could have told them a year ago. @EricSchmidt151 says that $REPL doesnt have the resources to do a randomized control trial. If they cannot lobby for accelerated approval this drug is never coming to market and will die Its surprising how this turned out. I would have liked to have heard from KOLs. #BiotechHangout"
@BiotechCH on X 2025-07-25 16:51:24 UTC 14.6K followers, XXX engagements

"On $REPLs CRL for its drug RP1 for advanced melanoma @EricSchmidt151 shares that The company was expecting to get approval certainly they were acting in ways that would have you believe they thought they were going to get approvalBut unfortunately that CRL threw them for a spin and it does seem like in this case it was someone higher up at the agency - we presume Dr. Prasad - who made the call here not to approve the drug saying that a single arm study was not adequate to support approval in oncology despite unmet need here. #BiotechHangout"
@BiotechCH on X 2025-07-25 16:49:41 UTC 14.6K followers, XXX engagements