Theralase Technologies Inc. V.TLT

Accelerated Approval

[ScienceFirst]

Very well written 2022 document 

https://pharmanewsintel.com/features/understanding-the-fdas-expedited-approval-pathways

[ScienceFirst]

    ACCELERATED APPROVAL For many medications, the effects and benefits take years to understand or appear. Taking that into account, the FDA has developed procedures to expedite the approval of these medications. The same year the FDA established the PDUFA, it instituted accelerated approval regulations. In 2021, 28% of approved drugs went through the

[Rumpl3StiltSkin]

With the BCG shortage and lack of anything even close, sorry Keytruda, It would seem 1433 would be granted AA? 

[Jaro1977]

Roger expined that we have to go through all the steps, no cutting corners, BTD and AA will move us through the line faster but no stages can be skipped

[Rumpl3StiltSkin]

Well that is interesting, If that was stated it sounds like what some here have been thinking lately. First we get BTD, then apply for AA. The numbers are good enough. Final FDA approval won't come until study 2 is complete. But AA could happen some time after they are granted BTD. At least that is what I've been thinking.

[ScienceFirst]

AA has always been after BTD.  TLT will also qualify for Priority Review, shaving another 6 months to market. AA will allow us to charge for treatment, so to cover our cost and more.

[stocksnbonds458]

Science, in my opinion AA  provides us with the 30 pound sledgehammer required for negotiations with big pharma, and I don't mean a JV. I mean a buyout. Remember, JV= ,  Buyout =

[DeathXray33]

Osmium 1829; colon cancer... I buy every week no matter the price... >1.072 mil

[Rumpl3StiltSkin]

Good job! And, BC great point. Colon Cancer is going to be big for TLT.

[Dumbledorf]

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