The silly argument that two prior CRLs doom Afrezza
Ever heard of the following drugs?
The above are all FDA approved drugs, that were twice rejected by the FDA before eventually being approved.
However, perhaps you want to know about diabetic drugs specifically. Especially any recent approvals done by the FDA in just the last couple of years. Well yes, there are two diabetic drugs that obtained approval by the FDA after initially being rejected twice. First there is Bydureon approved by the FDA in 2012, and then there is Nesina approved by the FDA in 2013.
So those naysayers who are arguing that: the prior two CRLs received by Afrezza pretty much kill any chances of it being approved this coming time around, really do not know what they are talking about. Especially when one reviews the reasons for Afrezza receiving the CRLs. In fact I would suggest those betting against Afrezza's approval, based upon prior history, need to go back and really do their due diligence regarding the circumstances around Afrezza's rejection by the FDA the last time around.
Anyways, if you are an investor betting against Afrezza's approval, simply because it was twice rejected previously, I would strongly suggest you reconsider your logic and position. Especially when one looks at the FDA's recent track record.
The approval rate is 20% higher for the first resubmission after a CRL. The approval rate climbs another 8.3% for a second submission. When investing in a biotech, CRLs are a positive, not a negative when looking at the statistical odds of FDA approval.
Bing it: "drug approval rate with CRL" and read this article: BIO Analysis: Resubmissions ...
Well said not only that this company has spent a freaking decade and over a billion use developing this drug,do you really think they would wait that long,peruse and spend almost 2 billion usd if they knew it was a hopeless case i mean really?Its time these twits in Motley fool etc get their senses together.