MSB (ASX) Cell Therapy News/Articles

Originally posted by Science1000: ↑

Great article Ratfink
I agree that the COVID trial with its placebo arm is the best way to rescue Rem-L for now.
Sadly for the kids, I see no secure rapid path to approval.

Unless the FDA are willing to link an accelerated approval (very limited with a heap of restrictions) to an emergency use approval (EUA) for Rem-L once there is adequate data for COVID ARDS, as the biology is similar. Which would be great.

I guess we don’t know if the conversations with the FDA have been including the COVID data.
It depends on how good the data are
and how great the unmet COVID need is heading into winter.

Again, that is tied up with introducing a new therapeutic realm into the FDA approval system - not just a new class of drug. They need to be able to monitor it, assess it and hold back the predators from the gates because the NYT list is the problem indeed. And that doesn’t begin to mention the pharma, IP and philosophical issues I discussed in my last post.

BTW If the COVID trial does produce good data, and if there is a huge unmet need,
who remembers how herceptin got approved? Who has read the book?
Her2 The Making of Herceptin, a revolutionary treatment of breast cancer.

That story was basically what women had to go through to get access to a treatment that saved lives, when they had the worst type of breast cancer that killed them and there was a treatment only available on clinical trials that many women couldn’t access. They picketed and demonstrated and eventually the FDA approved this novel drug. And the rest..... is history. And herceptin remains the poster child for solid tumour targeted therapy.

The public, as advocates or consumers are correctly known, were required to make a difference, because the type of treatment was so new.

They had three trials. We need enough data too - which we don’t have yet.
The previous understanding for children (no placebo control arm) was obviously not with enough of the FDA.

so, data, unmet need, FDA attention for COVID ARDS.
in that order.
and hopefully CHF and Back pain backing it up.
IMO

Expand

Hopefully, I'm wrong about the Type A, but if I'm not it is just more time that we are wasting. What puzzles me about the FDA ruling is that MSB would have had a meeting with the FDA when they were designing the trial. Did MSB not understand what the FDA said at that meeting? Something does not add up.

"Unless the FDA are willing to link an accelerated approval (very limited with a heap of restrictions) to an emergency use approval (EUA) for Rem-L once there is adequate data for COVID ARDS, as the biology is similar. Which would be great."

As much as I'd like to think otherwise, I'm not sure the FDA would consider any data from the ARDS trial for the GVHD indication. Let's not forget that should MSB gain approval for C19 ARDS, they are likely to need further trial data for ARDS caused by flu or other ailments.

Also, thanks heaps for the background and info on Herceptin as I was unaware of it. I have a very close family member who has late stage breast cancer and is trying a bunch of stuff at the moment. I'll call her tonight to see if she's aware of it.

All is not lost for us Mesoblast shareholders, far from it. Now that most of the traders have abandoned ship we may start to become a little more civil on HC again

Originally posted by Science1000: ↑

Great article Ratfink
I agree that the COVID trial with its placebo arm is the best way to rescue Rem-L for now.
Sadly for the kids, I see no secure rapid path to approval.

Unless the FDA are willing to link an accelerated approval (very limited with a heap of restrictions) to an emergency use approval (EUA) for Rem-L once there is adequate data for COVID ARDS, as the biology is similar. Which would be great.

I guess we don’t know if the conversations with the FDA have been including the COVID data.
It depends on how good the data are
and how great the unmet COVID need is heading into winter.

Again, that is tied up with introducing a new therapeutic realm into the FDA approval system - not just a new class of drug. They need to be able to monitor it, assess it and hold back the predators from the gates because the NYT list is the problem indeed. And that doesn’t begin to mention the pharma, IP and philosophical issues I discussed in my last post.

BTW If the COVID trial does produce good data, and if there is a huge unmet need,
who remembers how herceptin got approved? Who has read the book?
Her2 The Making of Herceptin, a revolutionary treatment of breast cancer.

That story was basically what women had to go through to get access to a treatment that saved lives, when they had the worst type of breast cancer that killed them and there was a treatment only available on clinical trials that many women couldn’t access. They picketed and demonstrated and eventually the FDA approved this novel drug. And the rest..... is history. And herceptin remains the poster child for solid tumour targeted therapy.

The public, as advocates or consumers are correctly known, were required to make a difference, because the type of treatment was so new.

They had three trials. We need enough data too - which we don’t have yet.
The previous understanding for children (no placebo control arm) was obviously not with enough of the FDA.

so, data, unmet need, FDA attention for COVID ARDS.
in that order.
and hopefully CHF and Back pain backing it up.
IMO

Expand

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Cell Therapy News/Articles, page-6984

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Cell Therapy News/Articles, page-6984

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