2020 - A Year Full Of Potentials, page-7

Hi Pfeifer1982,

Like always, your post are full of research and fact's.

In your post above you mention, the FDA.

While this is very important mile stone, for the company, once we have received the FDA approval.

I have been thinking about and it is really, has not been discussed, here in great depth.

We did receive an announcement back on 28th March 2018. (See Below).

Melbourne, Australia; 28 March 2018: Australian stem cell and regenerative medicine company,
Cynata Therapeutics Limited (ASX: CYP) is pleased to announce that the United Stated Food and Drug
Administration (FDA) has granted Cynata Orphan Drug Designation for CYP-001 for the treatment of
acute graft versus host disease (GvHD). CYP-001 is the lead mesenchymal stem cell (MSC) product
manufactured using Cynata’s proprietary Cymerus platform manufacturing technology.

Key Highlights:
• Orphan Drug Designation means CYP-001 is eligible for important incentives, including an
extended period of marketing exclusivity, tax credits and FDA fee waivers.

• Positions CYP-001 for cost-effective commercialisation in the USA – the world’s largest
healthcare market.

Orphan Drug Designation

An Orphan Drug is a therapeutic agent used for the prevention, diagnosis or treatment of a rare
disease, which is defined as a disease or condition that affects fewer than 200,000 people in the USA.

Once a product has been granted Orphan Drug Designation by the FDA, the sponsor or manufacturer
of that product can take advantage of three special and commercially significant incentives:

• Exclusivity – the potential to receive seven years of marketing exclusivity after FDA marketing
approval is granted.
• Tax credit – half of the qualified clinical research costs for a designated orphan product may
be claimed as tax credits in the USA.
• Waiver of FDA fees.

http://files.cynata.com/327/18.03.28.FDA-Grants-Orphan-Drug-Designation-to-Cynata-for-CYP-001.pdf

Unfortunately we will not see the approval or grant, till we have gone through our Phase 3 trial, in GVHD, only, (IMHO).

But if we do get this approval, for GVHD only, surely you would think, that in an Take Over situation, that is worth at least another 2 dollar's to our share price.

I hope our current board, are putting pressure on Fuji, to commence our Phase 2 trial, sooner rather than later.

IMHO.

Regards

Rossi70