I summarise my understanding for a bit.

 

So apparently Aytu was importing Zhejiang / Healgen' s products beforehand. They declared that NMPA, China' s version of the FDA, had not approved it yet (also, " A U.S. expert said the Chinese agency is considered " rigorous" and " demanding" in its oversight of products" so quite credible la ah). At that time, US-side/FDA was ok. But on 1 April, China' s NMPA  banned exports if they never approve.

 

At that point, Aytu was supplying some organisations in Colorado already. So now Aytu has orders to fill, but no supplier. Problem. Opportunity for Bio.

 

Very interestingly, on April 10, Aytu released a press release that said that they had " placed an order for 1 million test kits from an unidentified manufacturer" and also have an " order for 500,000 tests was " awaiting customs clearance" " . Remember, they announced exclusive distributorship agreement yesterday on 23/04 only. Any guesses who the unidentified manufacturer is?

 

My guess is Biolidics lor. If that' s true, not only confirmed sales, but sales arrived in US already liao. Never announce at point of sale because maybe that time not exclusive distributor yet, so maybe not material (or maybe that' s why halt ahah)

 

So NMPA approval means high chance of FDA approval. Also, initial sales look like its locked in already. It looks promising to me le. Not sure yet about the price fluctuations. While I' m sure Abbott and Roche will remain markets leaders in the US (once they actually manage to ramp up manufacturing in a few months), it looks like Biolidics+Aytu will do quite well for themselves also. A main reason is that they are moving lightning fast.

 

I don' t know how to analyse stocks like you experts, so I just do this kind of research and use my experience. Does it make sense?

Aytu BioScience Announces Exclusive Distribution Agreement for COVID-19 IgG/IgM Rapid Test with Singapore-Based Biolidics Limited

 

 

ENGLEWOOD, CO / ACCESSWIRE / April 23, 2020 /  Aytu BioScience, Inc. (NASDAQ:AYTU) (the " Company" ), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced the signing of a definitive agreement (the " Agreement" ) with Singapore-based Biolidics, Limited (SGX: 8YY " Biolidics" ) to exclusively distribute Biolidics' COVID-19 IgG/IgM Rapid Test in the United States.

Under the terms of the Agreement, Aytu will exclusively distribute Biolidics' COVID-19 IgG/IgM rapid antibody test in the United States. Aytu has committed to purchase 500,000 tests within one business day from the date of signing of the Agreement. As an additional component of Aytu' s exclusivity, the Company has committed to purchase a minimum of 1,250,000 tests within the first three months of the Agreement.

Biolidics' COVID-19 IgG/IgM Rapid Test has been issued Provisional Authorization for distribution by Singapore' s Health Science' s Authority (HSA), and the product has been authorized for export from Singapore. Biolidics' COVID-19 IgG/IgM Rapid Test will be supplied from Biolidics' facility in Singapore.

Aytu will collaborate with Biolidics and lead the U.S. clinical trials processes and plans to complete and obtain U.S. Food and Drug Administration (" FDA" ) 510k regulatory filing clearance of the COVID-19 IgG/IgM rapid test kits.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, " We are pleased to be partnering with Biolidics in distributing this COVID-19 rapid test in the U.S. With the continued call in the United States for increased COVID-19 testing, we are entering this distribution Agreement at an excellent time. We have experienced significant demand for our current COVID-19 rapid test, so adding this test to our product offering will enable us to better meet the high demand in the U.S. We look forward to a productive working relationship with Biolidics and thank them for their confidence in allowing Aytu to take this product to market in the United States."

Incorporated in 2009 and listed on the Singapore Stock Exchange, Biolidics Limited is a Singapore-based precision medicine medical technology company with a focus in developing a portfolio of innovative diagnostic solutions to lower healthcare costs and improve clinical outcomes.