I hate to say this but the recent warranted investigation into the FDA and Janet Woodcock etc..and all the issue with regards to the controversy over the FDA's approval of Biogen's Alzheimer's disease drug Aduhelm has effected the approval process at the FDA. I am fearful that any new therapy regardless of how safe and effective it might be, could be stalled and further delayed. I have a feeling that the decision maker at the FDA are scared to put their neck out on the line to approve a drug unless they have an insumountable amount of indisputable evidence regarding its effectiveness and efficiency with regard to a treatment. Which could further delay treatments that are possibly effective and efficient etc...further limiting the treatment options for patient suffering from deadly debilitating ailments with unmet medical needs.... especially if the drug is being developed by a small biotech company with limited funds to run a large scale trial.
In fact I was recently reviewing the conference call transcript https://ir.sesenbio.com/static-files/cb6d46da...8c18711b71 from SENSE this week to determine why they received a CRL on Monday 08/16 and they clearly state that " There is an unprecedented level of scrutiny at the FDA – maybe the most scrutiny we have seen since the early 1960s. First of all, there was the approval of the Alzheimer’s drug in June despite a very negative Advisory Committee (Adcom) vote. And at least three of the Adcom members stepped down. That triggered an independent review by the Office of Inspector General of the FDA, which is very unusual. There has been tremendously heavy, toxic media coverage. And still there is no permanent FDA commissioner and several senior positions are not filled, so there is a kind of leadership vacuum. Here the Agency is with all that going on, plus the unbelievable pressure of trying to work in a pandemic with an extreme focus on COVID vaccines and treatment. " and "They are working in a white-hot light. And it is easy to see why they might be, as you say, more conservative or risk averse. We saw an analysis recently confirm that– from January to early June, only about 15% percent of the FDA’s decisions resulted in a Complete Response Letter. But from early June until now, roughly 50% of FDA decisions have been complete response letters. When you are under pressure, the risk-averse or the safer strategy, will always be to punt the ball down the field and to ask for more data."
This is incredibly unfortunate and disheartening at a time in a pandemic when we need treatments and therapy options approved to save lives now.... not 1-2 years later. Regardless I continue to hope and pray our trail in Brazils trail knocks it out of the ball park because the world needs our help and we don't need any additional road blocks in our way especially not from the FDA.
I hope everyone has a great weekend and appreciate the continued contribution many of you make on this message board as we continue to seek trusted & truthful information and realistically positive perspectives about our investments in CYDY and how leronlimab could change the world we live in.
In fact I was recently reviewing the conference call transcript https://ir.sesenbio.com/static-files/cb6d46da...8c18711b71 from SENSE this week to determine why they received a CRL on Monday 08/16 and they clearly state that " There is an unprecedented level of scrutiny at the FDA – maybe the most scrutiny we have seen since the early 1960s. First of all, there was the approval of the Alzheimer’s drug in June despite a very negative Advisory Committee (Adcom) vote. And at least three of the Adcom members stepped down. That triggered an independent review by the Office of Inspector General of the FDA, which is very unusual. There has been tremendously heavy, toxic media coverage. And still there is no permanent FDA commissioner and several senior positions are not filled, so there is a kind of leadership vacuum. Here the Agency is with all that going on, plus the unbelievable pressure of trying to work in a pandemic with an extreme focus on COVID vaccines and treatment. " and "They are working in a white-hot light. And it is easy to see why they might be, as you say, more conservative or risk averse. We saw an analysis recently confirm that– from January to early June, only about 15% percent of the FDA’s decisions resulted in a Complete Response Letter. But from early June until now, roughly 50% of FDA decisions have been complete response letters. When you are under pressure, the risk-averse or the safer strategy, will always be to punt the ball down the field and to ask for more data."
This is incredibly unfortunate and disheartening at a time in a pandemic when we need treatments and therapy options approved to save lives now.... not 1-2 years later. Regardless I continue to hope and pray our trail in Brazils trail knocks it out of the ball park because the world needs our help and we don't need any additional road blocks in our way especially not from the FDA.
I hope everyone has a great weekend and appreciate the continued contribution many of you make on this message board as we continue to seek trusted & truthful information and realistically positive perspectives about our investments in CYDY and how leronlimab could change the world we live in.
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