Ann: FDA Breakthrough Device Designation, page-70

Diego, - perhaps also look at the cash balance of Manhattan Scientific!

As of 31 Mary 2019 - they had $36,000 USD in the bank (see link below).

Not only that - have a look at the accounts payable ($257k USD) and accrued expenses to related parties ($1.6m USD).

Their shares just came out of escrow. They have 64m shares. 140m shares traded today for $8.7m value with almost all day traders holding losses on this stock given the VWAP. Quite likely Manhattan were dumping to save their own Company from going into Chapter 11 or to ensure Manhattan could repay all those accrued expenses to related parties (i.e. themselves/their own directors). That their creditors were "related parties" is the only reason they are probably not in Chapter 11.

Link: https://www.sec.gov/Archives/edgar/data/1099132/000147793219003006/mhtx_10q.htm